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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916093
• Other study ID #: MinyaU
• Status: Completed
• Phase: Phase 4
• Start date: December 20, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: June 2021
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2020
• Est. primary completion date: June 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Vildagliptin 50 MG
Galvus 50 mg oral tablets
• Sitagliptin 100mg
Januvia 100mg oral tablets
• MetFORMIN 1000 Mg Oral Tablet
Glucophage 1000 mg oral tablets

Locations

Country	Name	City	State
Egypt	Minya University Hospital	Minya

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glycemic parameters	serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl)	3-months
Primary	Changes in Serum insulin (IU/l)	using enzyme immunoassay (EIA) kits	3-months
Primary	Insulin resistance	measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405	3-months
Primary	Beta cell function (HOMA-B)	measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63)	3-months
Primary	Changes in HbA1c (%)	Changes in HbA1c (%)	3-months
Secondary	Changes in Lipid profile	(total cholesterol, TG, HDL, and LDL) (mg/dl)	3-months
Secondary	Changes in liver enzymes	ALT and AST (U/l)	3-months
Secondary	Changes in Renal function tests	creatinine and urea (mg/dl)	3-months