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Liraglutide In Overweight Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01753362
Recruitment Status : Completed
First Posted : December 20, 2012
Results First Posted : December 17, 2019
Last Update Posted : December 17, 2019
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Paresh Dandona, University at Buffalo

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: liraglutide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: LIRAGLUTIDE IN OVERWEIGHT PATIENTS WITH TYPE 1 DIABETES
Study Start Date : December 2012
Actual Primary Completion Date : December 2017
Actual Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Liraglutide

Arm Intervention/treatment
Placebo Comparator: placebo
subcutaneous daily injection
Drug: placebo
Active Comparator: liraglutide
subcutaneous daily injection
Drug: liraglutide



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 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 Outcome Measures :
  1. Glucose Concentrations [ Time Frame: 26 weeks ]
    Mean daily glucose concentrations at baseline and 26 weeks



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753362


Locations
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United States, New York
diabetes endocrinology center of WNY
Buffalo, New York, United States, 14215
Diabetes Endocrinology Research Center of WNY
Buffalo, New York, United States, 14215
Sponsors and Collaborators
University at Buffalo
Juvenile Diabetes Research Foundation
Investigators
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Principal Investigator: Paresh Dandona, MBBS SUNY UB
  Study Documents (Full-Text)

Documents provided by Paresh Dandona, University at Buffalo:
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Responsible Party: Paresh Dandona, MD, University at Buffalo
ClinicalTrials.gov Identifier: NCT01753362    
Other Study ID Numbers: 1965
First Posted: December 20, 2012    Key Record Dates
Results First Posted: December 17, 2019
Last Update Posted: December 17, 2019
Last Verified: December 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Body Weight
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists