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Liraglutide in the Treatment of Type 1 Diabetes Mellitus
Phase 3 trial testing Liraglutide in Type 1 Diabetes in 72 participants. Completed in 1 December 2014.
| Lead sponsor | University at Buffalo |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 72 |
| Start date | 1 November 2012 |
| Primary completion | 1 April 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across United States |
University at Buffalo
Adults 18 to 75, female only, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary endpoint of the study is to detect a difference from baseline in mean weekly blood glucose concentrations before and after 12 weeks of treatment in each of the Liraglutide groups.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 1 | ± 0 |
| Liraglutide 1.8mg | -10 | ± 1 |
| Liraglutide 1.2mg | -10 | ± 2 |
| Liraglutide 0.6 mg | -0.3 | ± 2 |
Change from baseline (week 0) in HbA1c at 12 weeks after treatment
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.30 | ± 0.15 |
| Liraglutide 1.8mg | -0.42 | ± 0.15 |
| Liraglutide 1.2mg | -0.78 | ± 0.15 |
| Liraglutide 0.6 mg | -0.26 | ± 0.17 |
Change in Body weight in Kg from baseline after 12 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -0.3 | ± 0.5 |
| Liraglutide 1.8mg | -4.8 | ± 0.7 |
| Liraglutide 1.2mg | -5.0 | ± 1.2 |
| Liraglutide 0.6 mg | -2.7 | ± 0.6 |
Total daily insulin dose = Basal insulin dose plus bolus insulin dose. Change from baseline in Total daily insulin dose at 12 weeks from treatment.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -3.4 | ± 0.7 |
| Liraglutide 1.8mg | -10 | ± 0.5 |
| Liraglutide 1.2mg | -12.1 | ± 0.7 |
| Liraglutide 0.6 mg | -2.8 | ± 0.7 |
Change in the Area Under Curve (AUC0h-5h) of glucose concentration measured following meal challenge of up to 5hrs performed at baseline (week 0) at 12 weeks following treatment.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 0.04 | ± 0 |
| Liraglutide 1.8mg | -0.55 | ± 10 |
| Liraglutide 1.2mg | -0.55 | ± 10 |
| Liraglutide 0.6 mg | -0.01 | ± 0.11 |
Change from baseline (0 week) in Daily Carbohydrate intake (in grams) at 12 weeks after treatment.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | -13.4 | ± 2.6 |
| Liraglutide 1.8mg | -46.4 | ± 1.6 |
| Liraglutide 1.2mg | -47.6 | ± 2.6 |
| Liraglutide 0.6 mg | -23.7 | ± 2.5 |
change from baseline (week 0) in glucagon concentrations following 12 weeks of treatment
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 5 | ± 3 |
| Liraglutide 1.8mg | 9 | ± 6 |
| Liraglutide 1.2mg | -6 | ± 9 |
| Liraglutide 0.6 mg | 7 | ± 4 |
Time frame: 12 weeks.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Liraglutide 1.8mg | Liraglutide 1.2mg | Liraglutide 0.6 mg |
|---|---|---|---|---|---|
| Transient Nausea | Gastrointestinal disorders | — | — | — | — |
Data from ClinicalTrials.gov NCT01722266 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
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