Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosiglitazone | Experimental | 4mg |
|
| Rosiglitazone placebo | Placebo Comparator | 4mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosiglitazone 4 mg | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| glycemic control at treatment 24-week measured by fasting plasma glucose and daily insulin dose, proportion of subjects who reduce total daily insulin dose after treatment of 8, 16, and 24 weeks | 8, 16, and 24 weeks |
Not provided
Inclusion:
Exclusion:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Nanjing | Jiangsu | 210008 | China | ||
| GSK Investigational Site |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077154 | Rosiglitazone |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Xian |
| Shanxi |
| 710032 |
| China |
| GSK Investigational Site | Beijing | 100029 | China |
| GSK Investigational Site | Beijing | 100034 | China |
| GSK Investigational Site | Beijing | 100730 | China |
| GSK Investigational Site | Beijing | 100853 | China |
| GSK Investigational Site | Shanghai | 200001 | China |
| GSK Investigational Site | Shanghai | 200032 | China |
| GSK Investigational Site | Shanghai | 200233 | China |
| GSK Investigational Site | Tianjin | 300052 | China |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |