Comparison of Vildagliptin vs. Glimepiride on Glucose Variability in Metformin Uncontrolled Type 2 Diabetic Patients

NCT01910441 | Terminated Phase 4 Results

• 1 other identifier: CLAF237AIN03
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the effect of Vildagliptin plus Metformin versus Glimepiride plus Metformin on glucose variability in T2DM patients.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Glycemic variability

Outcome Measures

Primary Outcomes (1)

• Mean Amplitude of Glycemic Excursions (MAGE)

  16 weeks

Study Arms (2)

Group A: Vildagliptin plus metformin

EXPERIMENTAL

Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).

Drug: Vildagliptin; Drug: Metformin

Group B: Glimepiride plus metformin

ACTIVE COMPARATOR

Participants received Glimepiride 1-6 mg once daily as an add-on to metformin (1000-1500mg daily).

Drug: Glimepiride; Drug: Metformin

Interventions

Vildagliptin DRUG

Vildagliptin 50 mg twice daily

Group A: Vildagliptin plus metformin

Glimepiride DRUG

Glimepiride 1-6 mg once daily

Group B: Glimepiride plus metformin

Metformin DRUG

Metformin (1000-1500 mg daily)

Group A: Vildagliptin plus metformin; Group B: Glimepiride plus metformin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have given written informed consent to participate in the study.
• Type 2 Diabetes Mellitus patients either Male or female from 18 - 75 years of age (both inclusive).
• Patients who are uncontrolled on metformin monotherapy for at least past 4 weeks (1000-1500 mg daily and HbA1c \> 7.5 - 9%).
• Patients with HbA1C levels within the range \> 7.5% - 9%. (If a past value is available within the last 12 weeks, it would be considered acceptable provided it was obtained after at least 4 weeks of metformin therapy 1000-1500 mg daily).

You may not qualify if:

• Age \> 75 years ; BMI \<22 or \>40 kg/m2
• Patients who are on Insulin therapy at the time of study entry.
• Type 1 Diabetes Mellitus patients.
• Patients with severe renal (creatinine clearance \< 50 ml/min) or hepatic impairment (including pre-treatment ALT or AST \> 3 x ULN).
• Creatinine clearance will be estimated from serum creatinine using Cockcroft-Gault formula (Cockcroft and Gault, 1976)
• Patients with contraindications as mentioned in the Summary of Product Characteristics (SPCs) for vildagliptin, metformin, glimepiride, vildagliptin plus metformin and glimiperide plus metformin.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin; glimepiride; Metformin

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; Biguanides; Guanidines; Amidines

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8200

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2013
• First Posted: July 29, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 28, 2015
• Results First Posted: October 28, 2015

Record last verified: 2015-09