A Phase 3 interventional study of Liraglutide 1.8mg and Placebo in Type 1 Diabetes, sponsored by University at Buffalo. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by University at Buffalo · Phase 3, Interventional, and Treatment
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.
The control of glucose homeostasis in subjects with type 1 diabetes is fragile since exogenous insulin cannot compensate for changing requirements and is not precise either in terms of the dose or the bio-availability of the insulin injected. Furthermore, in the near total absence of insulin secretion, the physiological post prandial inhibition of glucagon secretion by the α-cell is also probably deficient in all type 1 diabetics. Thus, there is a need for therapies beyond insulin that can further improve glycemic control and reduce fluctuations in glucose in these subjects. The investigators have recently shown that Liraglutide, a glucagon like peptide (GLP)-1 analogue with duration of action of 24 hours, when added to insulin in subjects with well controlled type 1 diabetes reduces mean and standard deviation of blood glucose, HbA1c and insulin requirements. Since C-peptide concentrations did not alter following Liraglutide, it is likely that the suppression of glucagon may have contributed to this effect. 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.
Aim 1.1: To compare the HbA1c, mean fasting, glucose, mean weekly glucose, standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring and the dose of insulin required prior to and following 52 weeks of treatment with 1.8 mg of liraglutide daily.
Aim 1.2: To compare the postprandial glucose concentrations following a test meal before and after 52 weeks of treatment with 1.8 mg of liraglutide daily.
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.
Aim 2.1: To compare the basal and postprandial glucagon and C-peptide concentrations following a test meal before and after 52 weeks of treatment with 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 treatment with 1.8 mg of daily subcutaneous liraglutide.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 69 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University at Buffalo is the lead sponsor of 73 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Daily Injection
Drug: Liraglutide 1.8mg
Daily Injection
Drug: Placebo
HbA1c (%)
HbA1c measured at baseline and after 52 weeks of treatment with Liraglutide or placebo.
Time frame: 52 Weeks
Mean Weekly Glucose Concentrations.
Mean weekly glucose concentrations measured by CGM at baseline and at 52 weeks
Time frame: 52 Weeks
Body Weight
Body weight in Kg measured at weeks 0 (baseline) and at 52 weeks after treatment with liraglutide or placebo
Time frame: 52 weeks
| Milestone | Liraglutide | Placebo |
|---|---|---|
| Started | 35 | 34 |
| Completed | 26 | 20 |
| Not completed | 9 | 14 |
HbA1c measured at baseline and after 52 weeks of treatment with Liraglutide or placebo.
| Percent of Hemoglobin (%) | Liraglutide | Placebo |
|---|---|---|
| week 0 | 7.92 ± 0.15 | 7.48 ± 0.18 |
| week 52 | 7.45 ± 0.12 | 7.58 ± 0.14 |
Mean weekly glucose concentrations measured by CGM at baseline and at 52 weeks
| mg/dL | Liraglutide | Placebo |
|---|---|---|
| week 0 | 173 ± 5 | 160 ± 6 |
| week 52 | 156 ± 6 | 156 ± 6 |
Body weight in Kg measured at weeks 0 (baseline) and at 52 weeks after treatment with liraglutide or placebo
| Kg | Liraglutide | Placebo |
|---|---|---|
| week 0 | 83.6 ± 3.8 | 84.1 ± 4.0 |
| week 52 | 80.5 ± 3.8 | 83.8 ± 4.0 |
Collected over 56 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liraglutide | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Placebo | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
Out of 69 patients enrolled in the study, 13 patients dropped out from the study before baseline/randomization visit (during the 30 days insulin dose optimization). Therefore, baseline data is from 29 and 27 patients only.
| Age, Customized(years) | Liraglutide 1.8mg | Placebo | Total |
|---|---|---|---|
| Age | 45 ± 2 | 47 ± 3 | 46 ± 2.5 |
| Sex/Gender, Customized(Participants) | Liraglutide 1.8mg | Placebo | Total |
|---|---|---|---|
| Gender — male | 12 | 14 | 26 |
| Gender — female | 17 | 13 | 30 |
| Race (NIH/OMB)(Participants) | Liraglutide 1.8mg | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 3 | 2 | 5 |
| White | 24 | 23 | 47 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 1 | 3 |
| HbA1c (%)(percentage of hemoglobin) | Liraglutide 1.8mg | Placebo | Total |
|---|---|---|---|
| Mean | 7.92 ± 0.19 | 7.50 ± 0.18 | 7.71 ± 0.18 |
| Body Mass Index (BMI)(Kg/m2) | Liraglutide 1.8mg | Placebo | Total |
|---|---|---|---|
| Mean | 28.9 ± 1.1 | 29.1 ± 1.6 | 29.0 ± 1.2 |
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