Liraglutide In Overweight Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

LIRAGLUTIDE IN OVERWEIGHT PATIENTS WITH TYPE 1 DIABETES

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753362
• Other study ID #: 1965
• Status: Completed
• Phase: Phase 3
• Start date: December 2012
• Est. completion date: February 2018

Study information

• Verified date: December 2019
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Overweight
• Type 1 Diabetes

Intervention

Drug:
• liraglutide

• placebo

Locations

Country	Name	City	State
United States	diabetes endocrinology center of WNY	Buffalo	New York
United States	Diabetes Endocrinology Research Center of WNY	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	26 weeks
Secondary	Glucose Concentrations	Mean daily glucose concentrations at baseline and 26 weeks	26 weeks