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The purpose of this study is to determine the effects of sitagliptin on glucose variability both after meals and overnight in adult patients with type 1 diabetes.
Improved post prandial glucose control with multiple daily injections of insulin in the DCCT study demonstrated significant reductions in microvascular complication. Similar to type 2 diabetes, patients with type 1 diabetes have a paradoxical increase in glucagon after meals which contribute to worsening post prandial glucose control. This proposed study is designed to determine if altering the glucagon axis by giving sitagliptin can improve glucose control in patients with type 1 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin | Active Comparator | Patients will receive sitagliptin for 4 weeks and then cross over to sugar pill |
|
| Sugar pill | Placebo Comparator | Subjects will receive sugar pill for 4 weeks and then cross over to active sitagliptin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin | Drug | Sitagliptin 100mg tablet taken orally once daily for 4 weeks and then switch over to sugar pill taken daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this pilot study is to compare 24-hour blood glucose values (overnight and pre- and post- prandial glucoses) in adult subjects with type 1 diabetes receiving either sitagliptin or placebo | Assessment done at week 4 and week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Determine differences in fructosamine values | baseline, 4 and 8 weeks | |
| Time spent in hypoglycemic and hyperglycemic excursions recorded on the DexCom STS continuous glucose monitor (CGM) at 3 time periods throughout the study | Assessed at week 4 and week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Satish Garg, MD | University of Colorado, Denver | Principal Investigator |
| Samuel L Ellis, Pharm.D. | University of Colorado School of Pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23186950 | Derived | Garg SK, Moser EG, Bode BW, Klaff LJ, Hiatt WR, Beatson C, Snell-Bergeon JK. Effect of sitagliptin on post-prandial glucagon and GLP-1 levels in patients with type 1 diabetes: investigator-initiated, double-blind, randomized, placebo-controlled trial. Endocr Pract. 2013 Jan-Feb;19(1):19-28. doi: 10.4158/EP12100.OR. | |
| 21923696 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 12, 2013 | |
| Reset | Jan 31, 2014 | |
| Release | May 19, 2014 | |
| Reset | Jun 19, 2014 | |
| Release | Jan 12, 2022 | |
| Reset | Jan 31, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 12, 2013 | Jan 31, 2014 | |||
| May 19, 2014 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sugar Pill | Drug | Sugar pill taken daily for 4 weeks and then switched over to active comparator of sitagliptin 100mg tablet taken daily for 4 weeks |
|
| Ellis SL, Moser EG, Snell-Bergeon JK, Rodionova AS, Hazenfield RM, Garg SK. Effect of sitagliptin on glucose control in adult patients with Type 1 diabetes: a pilot, double-blind, randomized, crossover trial. Diabet Med. 2011 Oct;28(10):1176-81. doi: 10.1111/j.1464-5491.2011.03331.x. |
| Jun 19, 2014 |
| Jan 12, 2022 | Jan 31, 2022 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011719 |
| Pyrazines |
| D002241 | Carbohydrates |