Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-2473 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to asses changes in glycosylated hemoglobin, fasting blood lipids and genetic polymorphism's in peroxisomal proliferator activated receptors--gamma receptor after 6 months of pioglitazone, once daily (QD), treatment.
The metabolic control in type 2 diabetes mellitus can be measured by means of glycosylated hemoglobin. A low value glycosylated hemoglobin indicates a good metabolic control, and has been shown to be associated with a better prognosis regarding diabetic complications. Type 2 diabetes is a disease with a profound genetic component. Peroxisome proliferator-activated receptor gamma is a transcription factor implicated in adipocyte differentiation, lipid and glucose metabolism. Peroxisome proliferator-activated receptor alfa is a transcription factor implicated in lipid oxidation and gluconeogenesis and is present in liver, kidney, heart, skeletal muscle and adipose tissue.
Pioglitazone is a thiazolidinedione that targets nuclear peroxisomal proliferator activated receptors, members of the super family of ligand activated transcription factors. Specifically, thiazolidinediones bind to the peroxisome proliferator-activated receptor gamma and affect transcription factors that influence expression of genes responsible for the production of proteins important in carbohydrate and lipoprotein metabolism. These include increases in glucose transporters 1 and 4 resulting in enhanced peripheral glucose utilization by fat and skeletal muscle.
This is a pharmacoepidemiological study to evaluate whether the individual genotype of the patients have any influence on the efficacy of pioglitazone.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone 15 mg QD + Sulphonylurea |
| ||
| Pioglitazone 30 mg QD + Sulphonylurea |
| ||
| Pioglitazone 15 mg QD + Metformin |
| ||
| Pioglitazone 30 mg QD + Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone and sulphonylurea | Drug | Pioglitazone 15 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in glycosylated hemoglobin. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Clinical Laboratory Tests (alanine transaminase, hematocrit and hemoglobin). | End of Treatment | |
| Change from baseline in Body Weight. | End of Treatment | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients receiving pioglitazone therapy.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| VP Clinical Science Strategy | Takeda Global Research and Developmnet Center Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple | Denmark | |||||
Not provided
| Label | URL |
|---|---|
| ACTOS® Package Insert | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Whole blood for DNA-analyses
|
| Pioglitazone and sulphonylurea | Drug | Pioglitazone 30 mg, tablets, orally, once daily and stable sulphonylurea therapy for up to 24 months. |
|
|
| Pioglitazone and metformin | Drug | Pioglitazone 15 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months. |
|
|
| Pioglitazone and metformin | Drug | Pioglitazone 30 mg, tablets, orally, once daily and stable metformin therapy for up to 24 months. |
|
|
| Percentage of treatment responders defined as a patient with 0.6% decrease in HbA1C from baseline visit to final visit or accomplishment of a HbA1c value at or below 6.5%. |
| End of Treatment |
| Change from baseline in beta-cell function (Homeostasis model assessment). | End of Treatment |
| Change from baseline in insulin resistance (Homeostasis model assessment). | End of Treatment |
| Change from baseline in fasting lipoproteins (total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein-cholesterol and triglycerides). | End of Treatment |
| Multiple |
| Iceland |
| Multiple | Norway |
| Multiple | Sweden |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D003924 | Diabetes Mellitus, Type 2 |
| D003923 | Diabetes Mellitus, Lipoatrophic |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D052439 | Lipid Metabolism Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D013453 | Sulfonylurea Compounds |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
Not provided
Not provided