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NCT01722266 · ClinicalTrials.gov registry record · Phase 3
Liraglutide in the Treatment of Type 1 Diabetes Mellitus
A Phase 3 study, sponsored by University at Buffalo.
- Completed
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT01722266 is a Phase 3 study that has completed, run by University at Buffalo. The registered enrollment target is 72 participants.
The verdict
NCT01722266, a Phase 3 study, has completed, sponsored by University at Buffalo.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Liraglutide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2012-11-01 |
| Est. Completion | 2014-12-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01722266
The ClinicalTrials.gov registry entry for NCT01722266 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University at Buffalo, which has 67 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01722266 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01722266 about?
NCT01722266 is a clinical study titled "Liraglutide in the Treatment of Type 1 Diabetes Mellitus". 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 conti...
What is the current status of trial NCT01722266?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2012-11-01. Estimated completion is 2014-12-01.
What interventions are being tested in trial NCT01722266?
The interventions under investigation include: Placebo (DRUG), Liraglutide (DRUG).
Who is sponsoring clinical trial NCT01722266?
This trial is sponsored by University at Buffalo, which has 67 total clinical trials registered on ClinicalTrials.gov.
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