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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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The purpose of this study is to examine the effects of liraglutide (a drug used to treat type 2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to insulin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | subcutaneous daily injection |
|
| liraglutide | Active Comparator | subcutaneous daily injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo. | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Concentrations | Mean daily glucose concentrations at baseline and 26 weeks | 26 weeks |
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Inclusion Criteria:
1) Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2) Using a continuous glucose monitoring device (CGM) or regularly measuring their blood sugars four times daily. 3) HbA1c of less than 8.5%. 4) Well versed with carbohydrate counting. 5) Age 18-75 years 6) BMI≥ 25kg/m2 7) Age at diagnosis of type 1 diabetes should be <30 years. 8) evidence of auto-immunity to beta cells (GAD-65 and islet cell antibody screen)
Exclusion Criteria:
1)Type 1 diabetes for less than 6 months; 2)Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3)Hepatic disease (transaminase > 3 times normal) or cirrhosis; 4)Renal impairment (serum eGFR <30ml/min/1.73m2); 5)HIV or Hepatitis B or C positive status; 6)Participation in any other concurrent clinical trial; 7)Any other life-threatening, non-cardiac disease; 8)Use of an investigational agent or therapeutic regimen within 30 days of study. 9) history of pancreatitis 10) pregnancy 11) inability to give informed consent 12) history of gastroparesis 13)history of medullary thyroid carcinoma or MEN 2 syndrome. 14) Smokers will be advised not to change their amount of smoking for the duration of the study; 15) Use of any agent other than insulin for treatment of diabetes (metformin, pramlintide or thiazolidinediones.
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| Name | Affiliation | Role |
|---|---|---|
| Paresh Dandona, MBBS | SUNY UB | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| diabetes endocrinology center of WNY | Buffalo | New York | 14215 | United States | ||
| Diabetes Endocrinology Research Center of WNY |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | subcutaneous daily injection placebo |
| FG001 | Liraglutide | subcutaneous daily injection liraglutide |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | subcutaneous daily injection placebo |
| BG001 | Liraglutide | subcutaneous daily injection liraglutide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | HbA1c | The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo. | Posted | Mean | Standard Deviation | percent | 26 weeks |
|
|
26 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 | Placebo | subcutaneous daily injection placebo | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paresh Dandona | University at Buffalo | 716-535-1850 | dandona@buffalo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2018 | Dec 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
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|
| Buffalo |
| New York |
| 14215 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Glucose Concentrations | Mean daily glucose concentrations at baseline and 26 weeks | Posted | Mean | Standard Deviation | mg/dL | 26 weeks |
|
|
|
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Liraglutide | subcutaneous daily injection liraglutide | 0 | 40 | 0 | 40 | 0 | 40 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |