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Liraglutide In Overweight Patients With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
liraglutide
placebo
Sponsored by
University at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • diabetes endocrinology center of WNY
  • Diabetes Endocrinology Research Center of WNY

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo

liraglutide

Arm Description

subcutaneous daily injection

subcutaneous daily injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Glucose Concentrations
Mean daily glucose concentrations at baseline and 26 weeks

Full Information

First Posted
December 17, 2012
Last Updated
December 3, 2019
Sponsor
University at Buffalo
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01753362
Brief Title
Liraglutide In Overweight Patients With Type 1 Diabetes
Official Title
LIRAGLUTIDE IN OVERWEIGHT PATIENTS WITH TYPE 1 DIABETES
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University at Buffalo
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
subcutaneous daily injection
Arm Title
liraglutide
Arm Type
Active Comparator
Arm Description
subcutaneous daily injection
Intervention Type
Drug
Intervention Name(s)
liraglutide
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
HbA1c
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.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Glucose Concentrations
Description
Mean daily glucose concentrations at baseline and 26 weeks
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paresh Dandona, MBBS
Organizational Affiliation
SUNY UB
Official's Role
Principal Investigator
Facility Information:
Facility Name
diabetes endocrinology center of WNY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Diabetes Endocrinology Research Center of WNY
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States

12. IPD Sharing Statement

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Liraglutide In Overweight Patients With Type 1 Diabetes

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