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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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To evaluate the effect of DPP-4 inhibition on glucagon counter-regulatory mechanisms at moderate hypoglycemia in metformin-treated subjects with T2DM
The glucagon response to mild (3.0 mmol/l) hypoglycemia with and without DPP-4 inhibition by sitagliptin will be evaluated in elderly subjects with metformin treated type 2 diabetes to explore whether DPP-4 inhibition affects glucagon counter-regulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin first, then placebo | Other | Sitagliptin treatment for four weeks, then washout for four weeks, then placebo for four weeks |
|
| Placebo first, then sitagliptin | Other | Placebo for four weeks, then washout for four weeks, then sitagliptin for four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 100 mg daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Glucagon Counterregulation to Hypoglycemia | Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo | Four weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bo Ahrén, MD, PhD | Lund University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skane University Hospital Malmö | Malmö | 20502 | Sweden |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin First, Then Placebo | Sitagliptin first for four weeks, then washout for four weeks, then placebo for four weeks |
| FG001 | Placebo First, Then Sitagliptin | Placebo first for four weeks, then washout for four weeks, then placebo for four weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin First, Then Placebo | Hypoglycemia clamp with sitagliptin Sitagliptin: Treatment with sitagliptin 100mg QD for four weeks followed by hyperinsulinemic hypoglycemic clamp |
| BG001 | Placebo First, Then Stagliptin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Glucagon Counterregulation to Hypoglycemia | Change in plasma glucagon to insulin-induced hypoglycemia after four weeks of treatment with sitagliptin and placebo | Posted | Mean | Standard Error | pmol/l | Four weeks treatment |
|
4 weeks
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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 First, Then Placebo | Sitagliptin first for four weeks, then washout for four weeks, then placebo for four weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Bo Ahrén | Lund University | +46462220758 | Bo.Ahren@med.lu.se |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 12, 2015 | Oct 18, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 12, 2015 | Dec 18, 2017 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| 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 |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
Placebo one tablet daily |
|
Hypoglycemia clamp with placebo
Placebo: Treatment with placebo QD for four weeks followed by hyperinsulinemic hypoglycemic clamp
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fasting glucagon | Mean | Standard Deviation | pmol/l |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo First, Then Stagliptin | Placebo first for four weeks, then washout for four weeks, then sitalgiptin for four weeks | 0 | 13 | 0 | 13 | 0 | 13 |
| EG002 | Sitagliptin | Sitagliptin 100mg Daily for four weeks, either before or after a 4 week placebo period | 0 | 28 | 0 | 28 | 0 | 28 |
| EG003 | Placebo | Placebo Daily for four weeks, efter before or after a 4 week sitagliptin period | 0 | 28 | 0 | 28 | 0 | 28 |
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| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |