Safety and Efficacy Study to Compare Vildagliptin to Pioglitazone as Adding on Metformin in Type 2 Diabetes

NCT01882907 | Completed Phase 4 Results DMC

• 1 other identifier: CLAF237AKR05T
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to compare the effect of 16 weeks treatment with vildagliptin to pioglitazone as add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy.

Conditions

Type 2 Diabetes

Keywords

vildagliptin; metformin

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of HbA1C Change From Baseline in Vildagliptin + Metformin Group Compared With Pioglitazone + Metformin Group

  16 weeks

Secondary Outcomes (4)

• the Mean Changes of FPG and PPG From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups

  16 weeks , visit 5

• the Mean Changes of Lipid Profiles From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups

  16 weeks, visit 5

• the Mean Changes of Body Weight From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups

  16 weeks, visit 5

• the Mean Changes of Insulin, C-peptide, HOMA-IR, HOMA-beta From Baseline Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups

  16 weeks, visit 5

Other Outcomes (1)

• the Numbers of Participants With Adverse Events Between Vildagliptin + Metformin and Pioglitazone + Metformin Groups

  16 weeks, visit 3,4,5

Study Arms (2)

vildagliptin

EXPERIMENTAL

vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy

Drug: vildagliptin

pioglitazone

ACTIVE COMPARATOR

Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy

Drug: Pioglitazone

Interventions

vildagliptin DRUG

vildagliptin 50mg bid for 16 weeks

Also known as: Galvus

vildagliptin

Pioglitazone DRUG

Pioglitazone 15mg bid for 16 weeks

Also known as: Actos

pioglitazone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age in the range of 18 to 80 years
• HbA1c 7 to 11%
• FPG \< 270 mg/dL (15 mmol/L);
• Agreement to maintain prior diet \& exercise
• Written informed consent to participate in the study

You may not qualify if:

• Type 1 diabetes or Any kind of secondary diabetes
• Pregnant or lactating women
• Acute infections which may affect blood glucose control within 4 weeks prior to visit 1.
• Significant diabetes complications e.g., symptomatic autonomic neuropathy or gastroparesis
• Previous history of severe cardiovascular disease such as
• Torsades de Pointes, sustained and clinically relevant ventricular tachycardia, or ventricular fibrillation
• Percutaneous coronary intervention within the past 3 months
• Any of the following within the past 6 months
• Myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with an MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor)
• Coronary artery bypass surgery
• Unstable angina
• Stroke
• Congestive heart failure (NYHA class I to IV)
• Liver disease such as cirrhosis or chronic active hepatitis
• Known sensitivity to pioglitazone, rosiglitazone, or similar drugs

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (15)

Busan Saint Mary's Medical Center

Busan, South Korea

Location

Dong-AUniversity Medical Center

Busan, South Korea

Location

Inje University Baik Hospital

Busan, South Korea

Location

Kosin University Hospital

Busan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Changwon Fatima Hospital

Changwon, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Kyungbuk National Universtiy Hospital

Daegu, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Chosun University Hospital

Gwangju, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Masan Samsung Medical Center

Masan, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

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

Results Point of Contact

• Title: In Joo Kim
• Organization: Pusan National University Hospital

injkim@pusan.ac.kr

+82-51-240-7224

Study Officials

• In Ju Kim, MD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 21, 2013
• Study Start: December 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 21, 2019
• Results First Posted: March 17, 2015

Record last verified: 2018-12

Locations

KR (15)