An Efficacy and Safety Study of Fixed-dose Rosiglitazone/Glimepiride to Treat Chinese Type 2 Diabetes Patients

NCT01453049 | Terminated Phase 3 Results

• 1 other identifier: 113263
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to demonstrate that the rosiglitazone/glimepiride fixed-dose combination tablet will safely and effectively control glycemia as first-line oral therapy in drug naïve subjects with type 2 diabetes. This 24-week study will compare the effects of treatment with rosiglitazone/glimepiride to treatment with glimepiride alone. The primary objective is to demonstrate superiority of rosiglitazone/glimepiride to glimepiride in lowering Glycosylated Hemoglobin (HbA1c).

Conditions

Diabetes Mellitus, Type 2

Keywords

rosiglitazone/glimepiride, fix dose, type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

  Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline.

  Baseline (Week 0) and Week 24

Secondary Outcomes (32)

• Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24

  Baseline (Week 0) and Week 24

• Number of HbA1c Responders and Non-responders

  Baseline (Week 0) and Week 24 (LOCF)

• Number of FPG Responders and Non-responders

  Baseline (Week 0) and Week 24 (LOCF)

• Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline

  Baseline (Week 0) and Week 24 (LOCF)

• Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW)

  Baseline (Week 0) and Week 24/EW

Study Arms (2)

fix dose of rosiglitazone/glimepiride

EXPERIMENTAL

4mg/1mg, 4mg/2mg, 4mg/4mg

Drug: rosiglitazone/glimepiride fix dose combination

glimepiride

ACTIVE COMPARATOR

1mg, 2mg, 4mg

Drug: glimepiride

Interventions

rosiglitazone/glimepiride fix dose combination DRUG

oral, once daily, dosage is titrated according to FPG and hypoglycemia events

Also known as: Avandaryl

fix dose of rosiglitazone/glimepiride

glimepiride DRUG

oral, once daily, dosage is titrated according to FPG and hypoglycemia

Also known as: Amaryl

glimepiride

Eligibility Criteria

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

You may qualify if:

• type 2 diabetes mellitus
• HbA1c between 7.5% and 11.0% at screening
• FPG between 7.0mmol/L and 13.3mmol/L at screening and at randomization visit
• subject was treated with diet and/or exercise alone
• QTc\<450mesc or QTc\<480msec for patients with bundle branch block
• Body Mass Index (BMI) \>19kg/m2
• Subject has given written informed consent

You may not qualify if:

• Documented history of significant hypersensitivity to thiazolidinediones, sulfonylureas, or compounds with similar chemical structures
• Ongoing edema or history of edema requiring pharmacological treatment in the 12 months prior to screening
• Presence of ischemic heart disease and/or peripheral arterial disease, or NYHA grade I-IV congestive heart failure
• Taking nitrates
• Clinically significant renal or hepatic disease
• Anemia
• Severe hypertriglyceridemia (TG\>=5.65mmol/L)
• Use of oral corticosteroids and Nicotinic acid
• Systolic blood pressure \<170mmHg, or diastolic blood pressure \> 100mmHg while on anti-hypertensive treatment
• Hyperthyroidism requiring treatment
• Diagnosed macular edema
• Women who are lactating, pregnant, or planning to become pregnant
• Presence of an active cancer or recently treated for cancer
• Drug/alcohol abuse
• Unwilling or unable to comply with the procedures described in the protocol

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (12)

GSK Investigational Site

Wuhan, Hubei, 430030, China

Location

GSK Investigational Site

Suzhou, Jiangsu, 215004, China

Location

GSK Investigational Site

Dalian, Liaoning, 116027, China

Location

GSK Investigational Site

Hangzhou, Zhejiang, 310003, China

Location

GSK Investigational Site

Hangzhou, Zhejiang, 310009, China

Location

GSK Investigational Site

Beijing, 100029, China

Location

GSK Investigational Site

Beijing, 100730, China

Location

GSK Investigational Site

Chongqing, 400016, China

Location

GSK Investigational Site

Shanghai, 200080, China

Location

GSK Investigational Site

Shenyang, 110003, China

Location

GSK Investigational Site

Tianjin, 300052, China

Location

GSK Investigational Site

Wuhan, 430022, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Rosiglitazone; glimepiride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 17, 2011
• Study Start: April 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 27, 2012
• Results First Posted: January 13, 2012

Record last verified: 2011-12

Locations

CN (12)