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Unanticipated delays due to sterilization/stabilization testing of GLP-1.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin + Pioglitazone PLACEBO | Experimental | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth |
|
| Sitagliptin + Pioglitazone | Experimental | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth |
|
| PLACEBO | Placebo Comparator | Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin + Pioglitazone PLACEBO | Drug | Sitagliptin 100 mg tablet daily + Pioglitazone PLACEBO 15 mg capsule daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Secretion | Not measured as study was prematurely terminated due to unanticipated delays. | baseline, 6 months, 9 months (after a 3 month washout) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mary Rhee, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | United States | ||
| Emory University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33210751 | Derived | Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2. |
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Only 3 control (normal glucose tolerance) subjects were enrolled to obtain results in normal subjects for the hyperglycemic clamp (without GLP-1 or arginine). No samples were run, and, therefore, there are no data for the control subjects.
No subjects with impaired glucose tolerance (IGT) were recruited or enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin + Pioglitazone PLACEBO | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth |
| FG001 | Sitagliptin + Pioglitazone | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth |
| FG002 | PLACEBO | Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin + Pioglitazone PLACEBO | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth |
| BG001 | Sitagliptin + Pioglitazone | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Secretion | Not measured as study was prematurely terminated due to unanticipated delays. | Posted | baseline, 6 months, 9 months (after a 3 month washout) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin + Pioglitazone PLACEBO | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone PLACEBO daily by mouth |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mary Rhee, M.D. | Emory University | 404-778-1666 | mrhee@emory.edu |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sitagliptin + Pioglitazone | Drug | Sitagliptin 100 mg tablet daily + Pioglitazone 15 mg capsule daily |
|
|
| PLACEBO | Drug | Sitagliptin placebo 100 mg tablet daily + Pioglitazone placebo 15 mg capsule daily |
|
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| BG002 | PLACEBO | Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth |
| BG003 | Total | Total of all reporting groups |
| participants |
| Sex: Female, Male | Count of Participants | Participants |
|
Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth
+ pioglitazone (TZD) PLACEBO daily by mouth
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Sitagliptin + Pioglitazone | Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth + pioglitazone (TZD) 15 mg daily by mouth | 0 | 0 | 0 | 0 |
| EG002 | PLACEBO | Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth + pioglitazone (TZD) PLACEBO daily by mouth | 0 | 0 | 0 | 0 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |