Primary outcomeMean· 26 weeks
HbA1c
| Group | Value (percent) | Spread |
|---|---|---|
| Placebo | 7.77 | 0.83 |
| Liraglutide | 7.94 | 1.05 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataLiraglutide In Overweight Patients With Type 1 Diabetes
NCTNCT01753362 (opens ClinicalTrials.gov in a new tab)Other id1965
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 84 participants (actual)
- Sponsor
- University at Buffalo · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Dec 2012
- Primary completion
- Dec 2017
- Completion
- Feb 2018
- First posted
- 20 Dec 2012 (estimated)
- Last update posted
- 17 Dec 2019
- Conditions
- Type 1 Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
2012201420162018
- Ph 3
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to examine the effects of liraglutide (a drug used to treat type 2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to insulin.
Interventions
- liraglutideDrug
- placeboDrug
Arms2
Placebo comparator
placebo
subcutaneous daily injection
Active comparator
liraglutide
subcutaneous daily injection
Primary outcomes1
Outcomes the sponsor listed as primary.
HbA1c
Time frame · 26 weeks
Registry description
The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo.
Secondary outcomes(1)
Glucose Concentrations
Time frame · 26 weeks
Registry description
Mean daily glucose concentrations at baseline and 26 weeks
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeMean· 26 weeks
Glucose Concentrations
| Group | Value (mg/dL) | Spread |
|---|---|---|
| Placebo | 183 | 6 |
| Liraglutide | 173 | 8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Placebosubcutaneous daily injection placebo | 0 / 26 | 0 / 26 | 0 / 26 |
| Liraglutidesubcutaneous daily injection liraglutide | 0 / 40 | 0 / 40 | 0 / 40 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
1\) Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2) Using a continuous glucose monitoring device (CGM) or regularly measuring their blood sugars four times daily. 3) HbA1c of less than 8.5%. 4) Well versed with carbohydrate counting. 5) Age 18-75 years 6) BMI≥ 25kg/m2 7) Age at diagnosis of type 1 diabetes should be \<30 years. 8) evidence of auto-immunity to beta cells (GAD-65 and islet cell antibody screen)
Exclusion Criteria:
1)Type 1 diabetes for less than 6 months; 2)Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3)Hepatic disease (transaminase \> 3 times normal) or cirrhosis; 4)Renal impairment (serum eGFR \<30ml/min/1.73m2); 5)HIV or Hepatitis B or C positive status; 6)Participation in any other concurrent clinical trial; 7)Any other life-threatening, non-cardiac disease; 8)Use of an investigational agent or therapeutic regimen within 30 days of study. 9) history of pancreatitis 10) pregnancy 11) inability to give informed consent 12) history of gastroparesis 13)history of medullary thyroid carcinoma or MEN 2 syndrome. 14) Smokers will be advised not to change their amount of smoking for the duration of the study; 15) Use of any agent other than insulin for treatment of diabetes (metformin, pramlintide or thiazolidinediones.
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