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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. Identifier: NCT01753362
Recruitment Status : Unknown
Verified February 2017 by Paresh Dandona, University at Buffalo.
Recruitment status was:  Recruiting
First Posted : December 20, 2012
Last Update Posted : November 6, 2017
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)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2012
Estimated Primary Completion Date : December 2017
Estimated 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 after 26 weeks of treatment with Liraglutide or placebo.

Secondary Outcome Measures :
  1. difference from baseline in mean weekly glucose concentrations [ Time Frame: 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

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 identifier (NCT number): NCT01753362

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Contact: Paresh Dandona, MD 716-898-1940

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United States, New York
diabetes endocrinology center of WNY Recruiting
Buffalo, New York, United States, 14215
Contact: Paresh Dandona, MD    716-898-1940   
Principal Investigator: Paresh Dandona, MD         
Diabetes Endocrinology Research Center of WNY Recruiting
Buffalo, New York, United States, 14215
Contact: Paresh Dandona, MD    716-898-1940   
Principal Investigator: paresh dandona, mbbs         
Sponsors and Collaborators
University at Buffalo
Juvenile Diabetes Research Foundation
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Principal Investigator: Paresh Dandona, MBBS SUNY UB

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Responsible Party: Paresh Dandona, MD, University at Buffalo Identifier: NCT01753362     History of Changes
Other Study ID Numbers: 1965
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Body Weight
Signs and Symptoms
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists