Phase 3
N=69
Liraglutide in Type 1 Diabetes
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01722240 ↗Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: HbA1c (%) — 7.92; 7.48; 7.45; 7.58 Percent of Hemoglobin (%)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liraglutide 1.8mg (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University at Buffalo
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c (%) |
7.92; 7.48; 7.45; 7.58 | — |
| SECONDARY Mean Weekly Glucose Concentrations. |
173; 160; 156; 156 | — |
| SECONDARY Body Weight |
83.6; 84.1; 80.5; 83.8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day.
- Regularly measuring blood sugars four times daily.
- HbA1c of less than 8.5%.
- Well versed with carbohydrate counting.
- Age 18-75 years.
- BMI 20-40 kg/m2
Exclusion Criteria
- Type 1 diabetes for less than 6 months;
- Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks;
- Hepatic disease (transaminase > 3 times normal) or cirrhosis;
- Renal impairment (serum eGFR < 30ml/min/1.73m2);
- HIV or Hepatitis B or C positive status;
- Participation in any other concurrent clinical trial;
- Any other life-threatening, non-cardiac disease;
- Use of an investigational agent or therapeutic regimen within 30 days of study.
- history of pancreatitis
- pregnancy
- inability to give informed consent
- history of gastroparesis
- history of medullary thyroid carcinoma or MEN 2 syndrome.
Data sourced from ClinicalTrials.gov (NCT01722240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.