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Liraglutide In Overweight Patients With Type 1 Diabetes

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by Paresh Dandona, University at Buffalo
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Paresh Dandona, University at Buffalo Identifier:
First received: December 17, 2012
Last updated: February 8, 2017
Last verified: February 2017
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 Intervention Phase
Type 1 Diabetes Drug: liraglutide Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Paresh Dandona, University at Buffalo:

Primary Outcome Measures:
  • 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:
  • difference from baseline in mean weekly glucose concentrations [ Time Frame: 26 weeks ]

Estimated Enrollment: 84
Study Start Date: December 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
subcutaneous daily injection
Drug: placebo
Active Comparator: liraglutide
subcutaneous daily injection
Drug: liraglutide


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01753362

Contact: Paresh Dandona, MD 716-898-1940

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
Principal Investigator: Paresh Dandona, MBBS SUNY UB
  More Information

Responsible Party: Paresh Dandona, MD, University at Buffalo Identifier: NCT01753362     History of Changes
Other Study ID Numbers: 1965
Study First Received: December 17, 2012
Last Updated: February 8, 2017

Additional relevant MeSH terms:
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 processed this record on August 18, 2017