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OpenTrials
Completed

NCT Number: NCT04916093

Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed 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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Minya University Hospital

Minya, 61118, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Vildagliptin 50 mg

Drug

Galvus 50 mg oral tablets

Sitagliptin 100mg

Drug

Januvia 100mg oral tablets

Metformin 1000 mg Oral Tablet

Drug

Glucophage 1000 mg oral tablets

Primary outcomes

  1. Changes in glycemic parameters

    Time frame: 3-months

    serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl)

  2. Changes in Serum insulin (IU/l)

    Time frame: 3-months

    using enzyme immunoassay (EIA) kits

  3. Insulin resistance

    Time frame: 3-months

    measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405

  4. Beta cell function (HOMA-B)

    Time frame: 3-months

    measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63)

  5. Changes in HbA1c (%)

    Time frame: 3-months

    Changes in HbA1c (%)

Secondary outcomes

  1. Changes in Lipid profile

    Time frame: 3-months

    (total cholesterol, TG, HDL, and LDL) (mg/dl)

  2. Changes in liver enzymes

    Time frame: 3-months

    ALT and AST (U/l)

  3. Changes in Renal function tests

    Time frame: 3-months

    creatinine and urea (mg/dl)

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • Minia University

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 7, 2021
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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