A Phase 3 interventional study of liraglutide and placebo in Type 1 Diabetes, sponsored by University at Buffalo. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-17.
Sponsored by University at Buffalo · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 84 is close to 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:
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.
subcutaneous daily injection
Drug: placebo
subcutaneous daily injection
Drug: liraglutide
HbA1c
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.
Time frame: 26 weeks
Glucose Concentrations
Mean daily glucose concentrations at baseline and 26 weeks
Time frame: 26 weeks
| Milestone | Placebo | Liraglutide |
|---|---|---|
| Started | 36 | 48 |
| Completed | 26 | 40 |
| Not completed | 10 | 8 |
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.
| percent | Placebo | Liraglutide |
|---|---|---|
| baseline | 7.77 ± 0.83 | 7.94 ± 1.05 |
| 26 week | 7.64 ± 0.84 | 7.60 ± 0.98 |
Mean daily glucose concentrations at baseline and 26 weeks
| mg/dL | Placebo | Liraglutide |
|---|---|---|
| baseline | 183 ± 6 | 173 ± 8 |
| 26 week | 172 ± 5 | 171 ± 9 |
Collected over 26 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Liraglutide | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Categorical(Participants) | Placebo | Liraglutide | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 36 | 58 |
| >=65 years | 4 | 4 | 8 |
| Age, Continuous(years) | Placebo | Liraglutide | Total |
|---|---|---|---|
| Mean | 47 ± 14.6 | 47 ± 13.0 | 47 ± 8.0 |
| Sex: Female, Male(Participants) | Placebo | Liraglutide | Total |
|---|---|---|---|
| Female | 16 | 26 | 42 |
| Male | 10 | 14 | 24 |
| Race (NIH/OMB)(Participants) | Placebo | Liraglutide | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 2 | 5 |
| White | 23 | 38 | 61 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Placebo | Liraglutide | Total |
|---|---|---|---|
| United States | 26 | 40 | 66 |
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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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University at Buffalo