Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes

Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes

The current study aims to investigate Sitagliptin and vildagliptin efficacy and safety compared to metformin as 1st line options for T2D patients.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Sitagliptin 100mg; Drug: Vildagliptin 50 MG; Drug: MetFORMIN 1000 Mg Oral Tablet

Detailed Description

This is a randomized case-controlled study in which drug-naive type-2 diabetic patients were divided into 3 groups and followed up for three months.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt, 61118
    • Minya university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Recently diagnosed type2 diabetic adult subjects who were not on an oral hypoglycemic drug (OHA) at the screening visit were eligible to participate.

Exclusion Criteria:

1. Type1 diabetes or ketoacidosis
2. End-organ failure as chronic renal failure (estimated serum creatinine level ≥ 1.5mg/dl in male and ≥ 1.4mg/dl in female)
3. Liver cell failure (elevated alanine transaminase (ALT ) and/or aspartate transaminase (AST) ≥ 2 folds)
4. Any stage of heart failure
5. Previous history of pancreatitis
6. Previous history of taking medication which may alter the efficacy of either drug eg: (other OHA drug, corticosteroids, and oral contraceptives)
7. Pregnant or lactating females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sitagliptin Group; Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast.	Drug: Sitagliptin 100mg; Januvia 100mg oral tablets
Experimental: Vildagliptin Group; Included 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper.	Drug: Vildagliptin 50 MG; Galvus 50 mg oral tablets
Active Comparator: Metformin Group; Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily	Drug: MetFORMIN 1000 Mg Oral Tablet; Glucophage 1000 mg oral tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in glycemic parameters	serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl)	3-months
Changes in Serum insulin (IU/l)	using enzyme immunoassay (EIA) kits	3-months
Insulin resistance	measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405	3-months
Beta cell function (HOMA-B)	measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63)	3-months
Changes in HbA1c (%)	Changes in HbA1c (%)	3-months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Lipid profile	(total cholesterol, TG, HDL, and LDL) (mg/dl)	3-months
Changes in liver enzymes	ALT and AST (U/l)	3-months
Changes in Renal function tests	creatinine and urea (mg/dl)	3-months

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: Minia University
• Investigators: Principal Investigator: Asmaa A Elsayed, Master, BUC

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2019
• Primary Completion (Actual): June 10, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: May 24, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate; Vildagliptin
• Other Study ID Numbers: MinyaU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes