INTRODUCTION:

Diabetes mellitus is a group of metabolic disorders characterized by persistent hyperglycemia resulting from impaired insulin secretion, insulin action, or both.¹ Type 2 diabetes mellitus (T2DM) is the most common form, accounting for over 90% of all diabetes cases globally.¹ According to the International Diabetes Federation, the global burden of diabetes is projected to rise from 371 million in 2012 to 552 million by 2030, with India alone expected to have over 79.4 million cases.²

Obesity, a chronic metabolic condition, is a major risk factor for the development and progression of T2DM and its complications, including non-alcoholic fatty liver disease (NAFLD), cardiovascular disease, and hypertension.³ Weight reduction of even 5–10% has been shown to improve insulin sensitivity and reduce the risk of these complications.⁴

Antidiabetic drugs vary in their impact on body weight. While sulfonylureas and insulin may cause weight gain, medications such as metformin, SGLT2 inhibitors, and GLP-1 receptor agonists are associated with weight neutrality or loss.⁵Individualized treatment strategies that consider both glycemic control and weight management are therefore essential, especially in overweight or obese individuals with T2DM.

MATERIAL AND METHODS:

Necessary approval from the Institutional Ethics Committee was obtained before initiating the study. (Approval No. DHR-EC/SC/2023/10/136)

Study Design:

Prospective, Observational Clinical study.

Study Site: Department of Pharmacology and Medicine, MGM Medical College, Kamothe, Navi Mumbai.

Study Duration: September 2023- February 2025.

Sample size: A Total 195 overweight and obese Type 2 Diabetic Patients were required to be included in the study.

A minimum of 195 overweight and obese Type 2 diabetes mellitus patients attending the Medicine OPD for consultation were enrolled in the study. Sample Size was calculated based on published study conducted by Vasanthakumar et al., 2020⁶

Sample size was calculated from the following formula of descriptive cross-sectional study. Sample Size Software, was used for sample size calculation with 5% level of signiﬁcance, 90% power and 10 % margin of error.

Formula: N = Z2 p (1-p) /d2

Where,

N = Estimated minimum sample size

Z=Standard deviation of 1.96 at 80% confidence interval

P= Prevalence of overweight and obesity among Type 2 diabetes mellitus patients was estimated to be 80%

Hence N = 195

Study Population: Type 2 diabetes mellitus (T2DM) patients who conform to the specified Inclusion Criteria were enrolled for the study.

Inclusion criteria:

• Newly /Previously diagnosed patients of Type 2 Diabetes mellitus

• Age between 30 to 70 years of either gender

• Patients with BMI equal or above 23mg/kg2

• T2DM patients with co-morbid conditions like hypertension, dyslipidaemia

• T2DM patients presenting with microvascular complications like retinopathy, nephropathy and neuropathy

• T2DM Patients who agree to sign the consent form

Exclusion criteria:

• T2DM Patient less than 30 and more than 70 years of age

• T2DM Patients with BMI <23mg/kg2

• Pregnant women, those who have gestational diabetes

• Patients with Type I Diabetes Mellitus

• T2DM Patient suffering from acute metabolic disorders like diabetic ketoacidosis or hyperosmolar coma

• T2DM Patients suffering from severe liver or kidney disease

• T2DM Patients who do not agree to sign the consent form.

Evaluation Parameters:

1. Patient characteristics:

· Demographic characteristics: Age, Gender

· Anthropometric indices: Height, Weight, BMI(Kg/m2)

BMI categorization as per WHO Criteria (Asia‑Pacific Region)

The Body Mass Index (BMI) categories are as follows: individuals with a BMI below 18.5 are classified as underweight; those with a BMI between 18.5 and 22.9 fall within the normal range; a BMI from 23.0 to 24.9 is considered overweight; and a BMI above 25 is categorized as obese.

· Generalized obesity (GO): Defined as a BMI≥25 Kg/m2

· Abdominal obesity (Waist/Hip ratio): Men >0.9, Female >0.85

· Life-Style Practices:

· Dietary Intake: Fruits and Vegetables, Total fat, free sugar and salt.

· Physical Activity: Moderate physical activity, vigorous physical activity.

· Addictions: Consumption of alcohol , smoked and smokeless tobacco.

2. Characteristics of Type 2 Diabetes Mellitus:

· Duration since the diagnosis of Type 2 DM: ≤ 10 years, 11-20 years, 21-30 years >30 years

· Glycemic Control: Good Glycemic Control (HbA1c less than 7 %)

· Concomitant Disease: Hypertension, Dyslipidaemia.

· Complications of Diabetes: Cardiovascular, Nephropathy, Neuropathy, Retinopathy and Diabetic foot

3. Prescription Pattern of Antidiabetic Drugs among Overweight and Obese T2DM

· Antidiabetic Medications (Class and Drug)

· Antidiabetic Medication and Insulin combinations

· Insulin

4. Impact of Antidiabetic drugs on Body Composition Indices

· Conducted among the newly diagnosed Type 2 diabetic patients prescribed OHA.

· The body composition indices assessed at baseline and 3 months

· Anthropometric parameters:

· Weight, BMI

· Body Composition indices using the Human Body composition analyser (CHL-818E)

· Total Body fat %

· Visceral fat index

· Skeletal muscle %

· Fat mass (FM)

· Fat mass index (FMI)

· Fat free mass index (FFMI)

· Ratio of fat to skeletal muscle

5. Impact of Antidiabetic drugs on Glycemic control

Impact of OHA on HBA1C, RBG and glycemic control was assessed at 3 months

Study Procedure:

The above-mentioned data and completed prescriptions were collected on predesigned case record form. All the diabetic patients attending the outdoor medicine department were screened and those eligible as per the inclusion criteria were enrolled. Written informed consent was obtained from each patient. The patient, lifestyle practices and disease profile were noted. The prescription pattern of antidiabetic drugs among Obese and overweight patients was assessed and compared.

The effect of antidiabetic drugs on body composition indices was studied among the newly diagnosed Type 2 diabetic patients. The anthropometric parameters and body composition indices were assessed at baseline and 3 months. The data was collected; analyzed and appropriate statistics were applied to obtain valuable information.

Data Analysis and Statistical Methods:

All data extracted was analysed using the Statistical Package for Social Sciences (SPSS) software. All continuous data was tested for normality using the Kolmogorov-Smirnov test. Normally distributed parameters were expressed as mean ± standard deviation, and nonnormally distributed parameters will be expressed as median and range. Differences in body composition indices was evaluated by t tests (continuous variables) or chi-square tests (categorical variables). If significant differences were found, Bonferroni post hoc analysis was used to assess individual differences. A 𝑃 value < 0.05 was considered statistically significant

RESULTS:

1) Characteristics of Patients with Type 2 diabetic patients:

a) Demographic and anthropometric profile:

· Age: A total of 200 individuals with type 2 diabetes, ages 18 to 70, were enrolled in this study. 10% of patients were between the ages of 18 and 30; 16.5% were between the ages of 31 and 40; 30.5% were between the ages of 41 and 50; 37.5% were between the ages of 51 and 60; 7% were between the ages of 61 and 70.

· Gender: Of the 200 patients, 44.5% percent were women and 55.5% percent were men

· Body Mass Index (BMI): Out of 200 patients, based on BMI, 76.5% overweight and 23.5% were found to be obese (Table 1)

Table 1: Patient profile, Disease Profile and Life style practices of Type 2 diabetic patients

Sr. No.	Parameters		Total
Sr. No.	Parameters		Value (N)	Percentage (%)
Patient profile
1	Age	18-30 Years	21	10%
		31-40 Years	31	16.5%
		41-50 Years	61	30.5%
		51-60 Years	75	37.5%
		61-70 Years	12	7%
2	Gender	Male	111	55.5%
2	Gender	Female	89	44.5%
3	BMI	Overweight	153	76.5%
3	BMI	Obese	47	23.5%
Disease profile
1.	Glycemic Control	Good Glycemic Control	60	30%
1.		Poor Glycemic Control	140	70%
2.	Complications Of Diabetes	Ocular	36	18%
2.	Complications Of Diabetes	Foot	19	9.5%
3.	Co-Morbidities	Obesity	47	23.5%
		Hypertension	40	20 %
		Hypolipidemia	29	14.5%
	Lifestyle Practices		Mean	SD
4	Physical Activity	Moderate Activity (Min/week)	69.839	61.83
4	Physical Activity	Vigorous Activity (Min/week)	35.17	30.95
5	Addictions	Smoked and Smokeless Tobacco (Times/day)	2.48	2.22
5	Addictions	Alcohol (ml)	42.1	36.88

b) Life style practices:

· Physical Activity: Mean time of 69.84± 61.83 minutes of were spent on moderate activity per day. On average, individuals engaged in 35.17±30.95 minutes of vigorous activity per day.

· Dietary Habits: The average intake of fruits/day was found to 235.4±33.23g. The average intake of vegetables/day was 203±33.23g. On average, 7.77±2.49 ml of saturated fat was consumed. On average, 106.5ml of unsaturated fat was consumed, with a high variation (SD = 140.71).

· Addictions: On average, individuals consumed 0.31 times smoked and smokeless tobacco per day, with a large variation (SD = 1.04). On average, individuals consumed 3.53±2.22 ml of alcohol.

c) Disease Profile of Type 2 diabetic patient:

· Duration of Diabetes: Among 200 patients, 74% have been living with diabetes for less than 10 years, 12% have had it for 11-20 years, and 1% have been diabetic for 21-30 years.

· Glycemic Control: 30% of the patients achieved good glycemic control, while 70% had poor glycemic control.

· Diabetes Complications: The complications seen in the patients include Ocular (18%), and Foot Complications (19%).

· Co-morbidities: The most common co-existing conditions found in the diabetic patients were Hypertension (20%), Dyslipidaemia (14.5%) and Obesity (23.5%), (Table 1)

2) Prescription Pattern:

B) Prescription pattern of Oral Hypoglycaemic Agents (OHA) among Obese/Overweight patients with Type 2 diabetes ¹⁸.

· OHA prescribed as Monotherapy: (Fig 1)

45 prescriptions used were prescribed as monotherapy, including Metformin (62.22%),

Sitagliptin (19.5%), Glimepiride (8.69%), and Dapagliflozin (8.69%).

Figure 1: OHA prescribed as Monotherapy

OHA prescribed as Combination therapy:

· Two Drug combination therapy: (Fig 2)

For two-drug Combination therapy (84 prescription), the most common prescribed combinations were Vildagliptin+Metformin (24.7%), Sitagliptin+ Metformin (29.4%), Glimepiride + Metformin (16.66%), Gliclazide+Metformin (9.41%), Sitagliptin+ Dapagliflozin (9.41%), and Dapagliflozin+Metformin (9.41%).

Figure 2: OHA prescribed as two drug Combination therapy

· OHA prescribed as Three, Four and five drug Combination therapy (Fig 3,4):

The details the distribution of 3-drug and 4-drug and 5 drug therapies prescribed. In 3-drug therapy (55 prescriptions), the most common combinations were Dapagliflozin+Sitagliptin+Metformin (36.3%), followed by Dapagliflozin+Vildagliptin+Metformin (16.3%). Other combinations included Gliclazide+Voglibose+ Metformin (5.5%) and Glimepiride+Voglibose+ Metformin (16.36%), with smaller proportions for other combinations such as Gliclazide+Glimepiride+ Metformin (1.81%), Teneligliptin+Repaglinide+ Metformin (3.6%), and Teneligliptin+Pioglitazone+ Metformin (3.6%).

For 4-drug therapy (15 prescriptions), the most frequent combination was Sitagliptin+Voglibose+Glimepiride+ Metformin (40%). Other notable combinations included Dapagliflozin + Glimepiride+Sitagliptin+Metformin (20%), Gliclazide+Voglibose+Dapagliflozin+ Metformin (20%), and Glimepiride+Voglibose+ Dapagliflozin+Metformin (13.3%). A smaller percentage (6.66%) involved the combination of Sitagliptin+Dapagliflozin+Gliclazide+Metformin.

5-drug therapy, there was one prescription involving a combination of Voglibose, Dapagliflozin, Vildagliptin, Gliclazide, and Metformin, making up 100% of the 5-drug therapy prescriptions.

Figure 3: OHA prescribed as three drug Combination therapy

Figure 4: OHA prescribed as four drug Combination therapy

3) Impact of OHA on BMI and Body composition indices:

Impact of OHA on BMI, Body composition, diabetes profile and glycaemic control was studied.

· BMI and Bodyweight (Table 2):

The BMI (Body Mass Index) values at baseline and after 3 months, along with the mean difference and the P-value. At baseline, the average BMI was measured, and after three months, there was a slight decrease. The p-value for this change was 0.034, which is below the standard significance threshold of 0.05. This indicates that the decrease in BMI over the three-month period was statistically significant, suggesting that the observed reduction was unlikely to be due to chance.

A significant (P=0.027) fall in bodyweight was observed at 3 months compared to baseline as the mean difference was -1.33±3.72 kg among Obese and Overweight after initiating over antidiabetic therapy. The baseline and 3 months value of Body composition indices (Total Body fat %, Visceral fat index, Skeletal muscle %, Fat mass (FM), Fat mass index (FMI), Fat free mass index (FFMI), Ratio of fat to skeletal muscle). A statically significant decrease in visceral fat index (P<0.05) was observed at 3 months as compared to baseline. In addiction increase in percentage of skeletal muscle (P<0.05) was observed at 3 months in comparison to baseline values. The other body composition (Total Body fat %, Fat mass (FM), Fat mass index (FMI), Fat free mass index (FFMI), Ratio of fat to skeletal muscle) were not statistically significant.

The HBA1cand RBS status of individuals at two different time points: baseline (0 months) and 3 months. A significant reduction in HBA1c (P<0.001), and RBS (P<0.001) was observed at 3 months compared to baseline values.

· Glycemic Control (Table 3):

At baseline (0 months), 6.45% individuals had good glycaemic control, while 93.5% individuals had poor glycaemic control. After 3 months, 29% individuals achieved good glycaemia control, while 70.96 % of individuals still had poor glycaemic control. The proportion of patients with good glycaemic control increased at 3 months as compared to baseline.

DISCUSSION:

Obesity is a growing global health concern that affects individuals of all age groups, including both children and adults. It is considered a chronic metabolic disorder with significant implications for public health. Obesity is closely associated with the development and progression of Type 2 Diabetes Mellitus (T2DM), forming a dangerous duo that significantly elevates the risk of complications such as cardiovascular disease, hypertension, and renal disorders⁴. Non-alcoholic fatty liver disease (NAFLD) is also commonly seen in obese individuals and shares a strong link with T2DM. These comorbidities not only increase morbidity but also contribute significantly to mortality rates worldwide.⁵

Clinical research has demonstrated that modest weight loss—ranging between 5% and 10% of initial body weight—can significantly reduce the risk and progression of NAFLD and Type 2 diabetes in at-risk populations. Therefore, weight management forms a crucial part of diabetes care, especially for overweight and obese patients.

Pharmacological management of T2DM includes a variety of oral hypoglycemic agents (OHAs), each with different mechanisms of action and varied effects on body weight. These drug classes include Sulfonylureas, Meglitinides, Biguanides, Thiazolidinediones, α-glucosidase inhibitors, DPP-4 inhibitors, SGLT-2 inhibitors, GLP-1 receptor agonists, and Amylin mimetics. Some antidiabetic medications are associated with weight gain (e.g., sulfonylureas, thiazolidinediones, insulin), while others are either weight-neutral (e.g., DPP-4 inhibitors, α-glucosidase inhibitors) or promote weight loss (e.g., metformin, SGLT-2 inhibitors, GLP-1 receptor agonists, and amylin analogues).

This differential impact on body weight highlights the importance of rational prescribing, particularly for overweight or obese individuals with T2DM. Choosing medications that are either weight-neutral or promote weight loss can help patients achieve better glycemic control while simultaneously aiding in weight management. In this context, drug utilization studies are valuable tools that help analyze prescribing trends and guide evidence-based clinical decision-making^.23

The present study aimed to examine the prescribing patterns of antidiabetic medications among overweight and obese patients diagnosed with T2DM and assess the impact of these medications on various body composition parameters and glycemic control.

In terms of monotherapy, Metformin emerged as the most frequently prescribed drug (62.22%), followed by Sitagliptin (19.5%), Glimepiride (8.69%), and Dapagliflozin (8.69%). These findings are in line with existing literature, reaffirming metformin’s position as the gold standard first-line agent for managing T2DM due to its efficacy, safety profile, and weight-reducing properties. Sitagliptin, a DPP-4 inhibitor with a weight-neutral profile, is also gaining popularity, particularly in patients where weight gain must be avoided. Dapagliflozin, an SGLT-2 inhibitor known for its weight-reducing and cardioprotective properties, was also prescribed, though less frequently. Interestingly, glimepiride, traditionally associated with weight gain, has shown some evidence of being weight-neutral in certain populations, which may explain its inclusion in therapy.

In two-drug combination therapies, the most commonly used combinations were Sitagliptin+Metformin (29.4%), Vildagliptin+Metformin (24.7%), Glimepiride +Metformin (16.66%), and Gliclazide+Metformin, each showcasing a rational combination aimed at improving glycemic control while minimizing side effects such as weight gain. Combinations involving metformin remain the cornerstone of dual therapy, consistent with global treatment guidelines. DPP-4 inhibitors and SGLT-2 inhibitors, when added to metformin, offer additional benefits such as weight neutrality or weight reduction, making them highly suitable for obese or overweight individuals.

In comparison to prior studies, the prescribing trends observed in the current study align well. Research conducted by Farjana Islam Aovi et al. (2016)^25,Mohamed Hassan Elnaem et al. (2020)²⁶, and Mushtaq S et al. (2014)²⁷ also highlighted DPP-4 inhibitors plus metformin as the most frequently prescribed combination therapies.

For three-drug regimens, Dapagliflozin+Vildagliptin+ Metformin (16.3%) and Dapagliflozin+Sitagliptin+ Metformin (36.3%) were commonly used. Additional combinations included Glimepiride+Voglibose+ Metformin and Gliclazide+Voglibose+Metformin. These combinations show a clinical shift towards including newer agents like SGLT-2 and DPP-4 inhibitors in advanced therapy lines, likely due to their weight and metabolic benefits.

The four-drug combinations featured Sitagliptin+ Voglibose+Glimepiride+Metformin (40%) as the most common, followed by Dapagliflozin+Glimepiride+ Sitagliptin+Metformin (20%). A single five-drug regimen containing Voglibose, Dapagliflozin, Vildagliptin, Gliclazide, and Metformin was also observed. These multi-drug approaches, though complex, reflect real-world scenarios where aggressive glycemic control is required for patients with multiple metabolic abnormalities.

Impact of OHA on BMI and body composition indices:

This study also evaluated the effect of OHAs on BMI and body composition. Significant reductions in BMI, body weight, and visceral fat index were observed over a 3-month period. Importantly, a significant increase in skeletal muscle mass percentage was also noted. Visceral fat is metabolically active and closely associated with insulin resistance; thus, its reduction is beneficial in improving metabolic outcomes. Likewise, increased skeletal muscle mass plays a critical role in glucose uptake and storage, supporting improved insulin sensitivity and glycemic control.²⁸

These findings emphasize that the improvement in metabolic health in overweight and obese T2DM patients is not solely about weight loss but also about favorable changes in body composition, particularly in reducing fat mass and increasing lean muscle mass.²⁸

Furthermore, glycemic control improved significantly over the 3-month treatment period. A larger proportion of patients achieved target HbA1c levels (less than 7%) by the end of the study. This reinforces the role of rational OHA selection in achieving both weight management and optimal glycemic outcomes.

However, the study is not without limitations. Being a single-center study, its findings may not be widely generalizable. The sample size was relatively small, limiting the statistical power of the findings. Additionally, the short follow-up duration (3 months) prevents assessment of long-term outcomes and sustainability of the observed benefits. Future research should consider multi-center studies, larger sample sizes, and extended follow-up periods to validate these findings and explore long-term impacts.

Despite these limitations, the study presents promising evidence supporting the rational use of weight-neutral or weight-lowering OHAs, particularly Metformin, SGLT-2 inhibitors, and DPP-4 inhibitors, in managing overweight and obese patients with T2DM. Avoiding agents that promote weight gain, such as sulfonylureas and thiazolidinediones, should be prioritized unless clinically indicated otherwise.

CONCLUSION:

In conclusion, the study found Metformin to be the most commonly prescribed monotherapy (62.22%), followed by Sitagliptin (19.5%), Glimepiride (8.69%), and Dapagliflozin (8.69%). For dual therapy, combinations such as Sitagliptin+Metformin (29.4%) and Vildagliptin +Metformin (24.7%) were most frequently used.

After 3 months of therapy with oral hypoglycemic agents, patients demonstrated significant improvements in BMI, body weight, visceral fat, and skeletal muscle mass, along with better glycemic control as evidenced by reduced HbA1c levels. These findings support the effectiveness of individualized pharmacologic strategies, emphasizing medications that support both glycemic targets and weight management.

The study underscores the importance of selecting antidiabetic medications based not only on glycemic efficacy but also on their impact on body weight and composition. For overweight and obese individuals with T2DM, medications like Metformin, SGLT-2 inhibitors, and DPP-4 inhibitors should be prioritized due to their favorable metabolic profiles.

CONFLICT OF INTEREST:

The authors have no conflicts of interest regarding this investigation.

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Received on 09.07.2025 Revised on 24.11.2025

Accepted on 15.02.2026 Published on 01.07.2026

Available online from July 04, 2026

Research J. Pharmacy and Technology. 2026;19(7):3181-3188.

DOI: 10.52711/0974-360X.2026.00452

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Sr No	Parameter	Mean baseline	Mean 3 months	Mean difference	P Value
1.	Bodyweight	69.43	68.09	-1.33	0.027
2.	BMI	29.45	28.76	-0.69	0.034
Body composition indices
1	Total Body Fat%	31.60±7.35	30.01±10.66	-1.59±6.32	0.169
2	Visceral Fat Index	13.13±3.11	12.62±2.96	1.54±0.50	0.039
3	Skeletal Muscle %	27.47±5.06	28.11±28.11	1.48±0.64	0.021
4	Fat Mass	21.91±6.97	29.44±41.68	7.53±40.82	0.312
5	Fat Mass Index	2.56±0.06	2.58±0.15	0.01±0.12	0.394
6	Fat Free Mass Index	20.54±7.80	20.43±8.65	-0.11±3.23	0.85

Sr No	Parameter	Baseline	3 months	P Value
1.	HBA1c (%)	9.61±1.88	7.67±1.22	0.001
2.	Random Blood Glucose (RBG) (mg/dl)	226.90±58.15	171.48 ±34.78	0.001
3	Good glycemic control (%)	6.45%	29.0%	0.05
4	Poor glycemic control (%)	93.5%	70.96%	0.05