Type 1 Diabetes
Conditions
Brief summary
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
DRUGliraglutide
DRUGplacebo
Sponsors
Juvenile Diabetes Research Foundation
University at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 26 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Glucose Concentrations | 26 weeks | Mean daily glucose concentrations at baseline and 26 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo subcutaneous daily injection
placebo | 26 |
| Liraglutide subcutaneous daily injection
liraglutide | 40 |
| Total | 66 |
Baseline characteristics
| Characteristic | Placebo | Total | Liraglutide |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 8 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 58 Participants | 36 Participants |
| Age, Continuous | 47 years STANDARD_DEVIATION 14.6 | 47 years STANDARD_DEVIATION 8 | 47 years STANDARD_DEVIATION 13 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 61 Participants | 38 Participants |
| Region of Enrollment United States | 26 participants | 66 participants | 40 participants |
| Sex: Female, Male Female | 16 Participants | 42 Participants | 26 Participants |
| Sex: Female, Male Male | 10 Participants | 24 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 40 |
| other Total, other adverse events | 0 / 26 | 0 / 40 |
| serious Total, serious adverse events | 0 / 26 | 0 / 40 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | HbA1c | 26 week | 7.64 percent | Standard Deviation 0.84 |
| Placebo | HbA1c | baseline | 7.77 percent | Standard Deviation 0.83 |
| Liraglutide | HbA1c | baseline | 7.94 percent | Standard Deviation 1.05 |
| Liraglutide | HbA1c | 26 week | 7.60 percent | Standard Deviation 0.98 |
Secondary
Glucose Concentrations
Mean daily glucose concentrations at baseline and 26 weeks
Time frame: 26 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Glucose Concentrations | baseline | 183 mg/dL | Standard Deviation 6 |
| Placebo | Glucose Concentrations | 26 week | 172 mg/dL | Standard Deviation 5 |
| Liraglutide | Glucose Concentrations | baseline | 173 mg/dL | Standard Deviation 8 |
| Liraglutide | Glucose Concentrations | 26 week | 171 mg/dL | Standard Deviation 9 |