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

NCT04916093 | Completed Phase 4 FDA Drug

• 1 other identifier: MinyaU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Changes in Lipid profile

  3-months

• Changes in liver enzymes

  3-months

• Changes in Renal function tests

  3-months

Study Arms (3)

Sitagliptin Group

EXPERIMENTAL

Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast.

Drug: Sitagliptin 100mg

Vildagliptin Group

EXPERIMENTAL

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

Metformin Group

ACTIVE COMPARATOR

Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily

Drug: MetFORMIN 1000 Mg Oral Tablet

Interventions

Vildagliptin 50 MG DRUG

Galvus 50 mg oral tablets

Vildagliptin Group

Sitagliptin 100mg DRUG

Januvia 100mg oral tablets

Sitagliptin Group

MetFORMIN 1000 Mg Oral Tablet DRUG

Glucophage 1000 mg oral tablets

Metformin Group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead
• Minia University: collaborator

Study Sites (1)

Minya University Hospital

Minya, 61118, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin; Sitagliptin Phosphate; Metformin; Tablets

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles; Azoles; Pyrazines; Biguanides; Guanidines; Amidines; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Asmaa A Elsayed, Master

  BUC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD candidate in clinical pharmacy department and PI

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 7, 2021
• Study Start: December 20, 2019
• Primary Completion: June 10, 2020
• Study Completion: December 15, 2020
• Last Updated: June 7, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)