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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04916093

Enrollment

Registered

2021-06-07

Start date

2019-12-20

Completion date

2020-12-15

Last updated

2021-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

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

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.

Interventions

DRUGSitagliptin 100mg

Januvia 100mg oral tablets

DRUGVildagliptin 50 MG

Galvus 50 mg oral tablets

DRUGMetFORMIN 1000 Mg Oral Tablet

Glucophage 1000 mg oral tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026