Liraglutide In Overweight Patients With Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Kaleida Health
Sponsor:
Information provided by (Responsible Party):
Paresh Dandona, MD, Kaleida Health
ClinicalTrials.gov Identifier:
NCT01753362
First received: December 17, 2012
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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 52 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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: LIRAGLUTIDE IN OVERWEIGHT PATIENTS WITH TYPE 1 DIABETES

Resource links provided by NLM:


Further study details as provided by Kaleida Health:

Primary Outcome Measures:
  • HbA1c [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 84
Study Start Date: December 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.

  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 ClinicalTrials.gov identifier: NCT01753362

Contacts
Contact: sandeep dhindsa, MBBS 716-626-7998 sdhindsa@kaleidahealth.org

Locations
United States, New York
diabetes endocrinology center of WNY Recruiting
Williamsville, New York, United States, 14224
Contact: Sonja Williams    716-626-7998    swilliams3@kaleidahealth.org   
Principal Investigator: Paresh Dandona, MD         
SUNY at UB, 115 flint road, Not yet recruiting
Williamsville, New York, United States, 14221
Contact: sandeep dhindsa, MBBS    716-626-7998    sdhindsa@kaleidahealth.org   
Principal Investigator: paresh dandona, mbbs         
Sponsors and Collaborators
Kaleida Health
Investigators
Principal Investigator: Paresh Dandona, MBBS SUNY UB
  More Information

No publications provided

Responsible Party: Paresh Dandona, MD, MD, Kaleida Health
ClinicalTrials.gov Identifier: NCT01753362     History of Changes
Other Study ID Numbers: 1965
Study First Received: December 17, 2012
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Overweight
Autoimmune Diseases
Body Weight
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Signs and Symptoms
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014