Phase 3
N=72
Liraglutide in the Treatment of Type 1 Diabetes Mellitus
Type 1 Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01722266 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Change in Mean Weekly Glucose Concentrations — 1; -10; -10; -0.3 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liraglutide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University at Buffalo
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Weekly Glucose Concentrations |
1; -10; -10; -0.3 | — |
| SECONDARY Change in HbA1c |
-0.30; -0.42; -0.78; -0.26 | — |
| SECONDARY Change in Body Weight From Baseline |
-0.3; -4.8; -5.0; -2.7 | — |
| SECONDARY Change in Total Insulin Dose From Baseline |
-3.4; -10; -12.1; -2.8 | — |
| SECONDARY Change in the Area Under Curve (AUC) of Glucose Following the Meal |
0.04; -0.55; -0.55; -0.01 | — |
| SECONDARY Change in Carbohydrate Intake |
-13.4; -46.4; -47.6; -23.7 | — |
| SECONDARY Change in Glucagon Concentrations |
5; 9; -6; 7 | — |
Summary
Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases fasting, postprandial and the overall mean glucose concentrations.
Aim 1.1: To compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following 6 weeks and 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. In addition, the time spent at glucose concentrations >150 and 200mg/dl and <70 and <40 mg/dl will also be compared.
Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily. Glucose concentrations will be measured as areas under the curve for the data obtained from the meal challenge.
Aim 1.3: To compare HbA1c levels(glycated hemoglobin) before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases postprandial glucagon concentrations and increases postprandial C-peptide concentrations.
Aim 2.1: To compare fasting and postprandial glucagon and C-peptide concentrations following a test meal before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.
Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying.
Aim 3.1: To compare the gastric emptying as measured by acetaminophen absorption before and after 12 weeks of treatment with 0.6, 1.2 and 1.8 mg of liraglutide daily.
Eligibility Criteria
Inclusion Criteria
- Patients with type 1 diabetes mellitus: Fasting c-peptide 3 times normal) or cirrhosis;
- Renal impairment (serum creatinine > 1.5);
- HIV or Hepatitis 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.
- Family history of MEN 2, Family history of medullary thyroid cancer, or familial medullary thyroid cancer
- Women of childbearing potential who are not using adequate contraception 16) Women who are pregnant
Data sourced from ClinicalTrials.gov (NCT01722266). 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.