Back to resultsSafety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Vildagliptin 50 MG
Sitagliptin 100mg
MetFORMIN 1000 Mg Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
- Minya University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Sitagliptin Group
Vildagliptin Group
Metformin Group
Arm Description
Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast.
Included 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper.
Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily
Outcomes
Primary Outcome Measures
Changes in glycemic parameters
serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl)
Changes in Serum insulin (IU/l)
using enzyme immunoassay (EIA) kits
Insulin resistance
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)
measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63)
Changes in HbA1c (%)
Changes in HbA1c (%)
Secondary Outcome Measures
Changes in Lipid profile
(total cholesterol, TG, HDL, and LDL) (mg/dl)
Changes in liver enzymes
ALT and AST (U/l)
Changes in Renal function tests
creatinine and urea (mg/dl)
Full Information
NCT ID
NCT04916093
First Posted
May 24, 2021
Last Updated
June 4, 2021
Sponsor
Beni-Suef University
Collaborators
Minia University
1. Study Identification
Unique Protocol Identification Number
NCT04916093
Brief Title
Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes
Official Title
Safety and Efficacy of Sitagliptin, Vildagliptin, and Metformin in Recently Diagnosed Drug-naïve Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
June 10, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
Minia University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sitagliptin Group
Arm Type
Experimental
Arm Description
Included 20 recently diagnosed type 2 diabetic subjects. They all received sitagliptin 100 mg therapy once daily before breakfast.
Arm Title
Vildagliptin Group
Arm Type
Experimental
Arm Description
Included 20 recently diagnosed type 2 diabetic subjects. They all received vildagliptin 50 mg therapy twice daily before breakfast and supper.
Arm Title
Metformin Group
Arm Type
Active Comparator
Arm Description
Included 20 recently diagnosed type 2 diabetic subjects. They all received control 1 gm twice daily
Intervention Type
Drug
Intervention Name(s)
Vildagliptin 50 MG
Intervention Description
Galvus 50 mg oral tablets
Intervention Type
Drug
Intervention Name(s)
Sitagliptin 100mg
Intervention Description
Januvia 100mg oral tablets
Intervention Type
Drug
Intervention Name(s)
MetFORMIN 1000 Mg Oral Tablet
Intervention Description
Glucophage 1000 mg oral tablets
Primary Outcome Measure Information:
Title
Changes in glycemic parameters
Description
serum fasting glucose (mg/dl), and 2-hr postprandial glucose (mg/dl)
Time Frame
3-months
Title
Changes in Serum insulin (IU/l)
Description
using enzyme immunoassay (EIA) kits
Time Frame
3-months
Title
Insulin resistance
Description
measured by HOMA model assessment (HOMA-IR) using the following formula: (Fasting insulin (IU/ml) × Fasting glucose (mg/dl))/405
Time Frame
3-months
Title
Beta cell function (HOMA-B)
Description
measured by (360 ×Fasting Insulin (IU/ ml) )/(Fasting glucose(mg/dl)-63)
Time Frame
3-months
Title
Changes in HbA1c (%)
Description
Changes in HbA1c (%)
Time Frame
3-months
Secondary Outcome Measure Information:
Title
Changes in Lipid profile
Description
(total cholesterol, TG, HDL, and LDL) (mg/dl)
Time Frame
3-months
Title
Changes in liver enzymes
Description
ALT and AST (U/l)
Time Frame
3-months
Title
Changes in Renal function tests
Description
creatinine and urea (mg/dl)
Time Frame
3-months
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa A Elsayed, Master
Organizational Affiliation
BUC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minya University Hospital
City
Minya
ZIP/Postal Code
61118
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Efficacy of Antidiabetic Drugs in Recently Diagnosed Patients With Type 2 Diabetes
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