Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

NCT00138554 | Completed Phase 3

• 1 other identifier: CLAF237A2304E1
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes; vildagliptin

Outcome Measures

Primary Outcomes (2)

• Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment

• Change from baseline in HbA1c at 52 weeks

Secondary Outcomes (5)

• Change in HbA1c between 24 weeks and 52 weeks

• Change from baseline in fasting plasma glucose at 52 weeks

• Change in fasting plasma glucose between 24 weeks and 52 weeks

• Change from baseline in HOMA B at 52 weeks

• Change from baseline in HOMA IR at 52 weeks

Study Arms (2)

vildagliptin 50 mg qd + pioglitazone 45 mg qd

EXPERIMENTAL

vildagliptin 50 mg qd + pioglitazone 45 mg qd for 28 weeks

Drug: vildagliptin; Drug: pioglitazone

vildagliptin 50 mg bd+ pioglitazone 45 mg qd

EXPERIMENTAL

vildagliptin 50 mg bd + pioglitazone 45 mg qd for 28 weeks

Drug: vildagliptin; Drug: pioglitazone

Interventions

vildagliptin DRUG

vildagliptin 50 mg bd+ pioglitazone 45 mg qd; vildagliptin 50 mg qd + pioglitazone 45 mg qd

pioglitazone DRUG

pioglitazone 45 mg qd

vildagliptin 50 mg bd+ pioglitazone 45 mg qd; vildagliptin 50 mg qd + pioglitazone 45 mg qd

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only patients successfully completing study CLAF237A2304 are eligible
• Written informed consent
• Ability to comply with all study requirements

You may not qualify if:

• Premature discontinuation from study CLAF237A2304

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

• Ligueros-Saylan M, Foley JE, Schweizer A, Couturier A, Kothny W. An assessment of adverse effects of vildagliptin versus comparators on the liver, the pancreas, the immune system, the skin and in patients with impaired renal function from a large pooled database of Phase II and III clinical trials. Diabetes Obes Metab. 2010 Jun;12(6):495-509. doi: 10.1111/j.1463-1326.2010.01214.x.

  PMID: 20518805 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vildagliptin; Pioglitazone

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; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2005
• First Posted: August 30, 2005
• Study Start: November 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)