Primary outcomeMean· 52 Weeks
HbA1c (%)
| Group | Value (Percent of Hemoglobin (%)) | Spread |
|---|---|---|
| Liraglutide | 7.92 | 0.15 |
| Placebo | 7.48 | 0.18 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataLiraglutide in Type 1 Diabetes
Short name 1966
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 69 participants (actual)
- Sponsor
- University at Buffalo · Other
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 1 Nov 2012
- Primary completion
- 1 Jan 2019
- Completion
- 29 Jul 2019
- First posted
- 6 Nov 2012 (estimated)
- Last update posted
- 23 Jan 2024
- Conditions
- Type 1 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20122014201620182020
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2 diabetes, however, these have not been studied prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed this study to investigate the central hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect. A major secondary objective of this study is to elucidate the mechanisms responsible for its glucose lowering effects and those involved in reducing the insulin dose. The specific aims of this proposal are: Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c, fasting, postprandial and the overall mean glucose concentrations while decreasing the dose of insulin required. Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and postprandial glucagon concentrations and increases basal and postprandial C-peptide concentrations. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying.
Interventions
- Liraglutide 1.8mgDrug
- PlaceboDrug
Arms2
Active comparator
Liraglutide 1.8mg
Daily Injection
Placebo comparator
Placebo
Daily Injection
Primary outcomes1
Outcomes the sponsor listed as primary.
HbA1c (%)
Time frame · 52 Weeks
Registry description
HbA1c measured at baseline and after 52 weeks of treatment with Liraglutide or placebo.
Secondary outcomes(2)
Mean Weekly Glucose Concentrations.
Time frame · 52 Weeks
Registry description
Mean weekly glucose concentrations measured by CGM at baseline and at 52 weeks
Body Weight
Time frame · 52 weeks
Registry description
Body weight in Kg measured at weeks 0 (baseline) and at 52 weeks after treatment with liraglutide or placebo
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeMean· 52 Weeks
Mean Weekly Glucose Concentrations.
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Liraglutide | 173 | 5 |
| Placebo | 160 | 6 |
Secondary outcomeMean· 52 weeks
Body Weight
| Group | Value (Kg) | Spread |
|---|---|---|
| Liraglutide | 83.6 | 3.8 |
| Placebo | 84.1 | 4.0 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LiraglutideDaily Injection | 0 / 26 | 0 / 26 | 0 / 26 |
| PlaceboDaily Injection Placebo | 0 / 20 | 0 / 20 | 0 / 20 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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. Regularly measuring 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 20-40 kg/m2
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.
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