Liraglutide In Overweight Patients With Type 1 Diabetes

NCT01753362 | Completed Phase 3 Results DMC

• 1 other identifier: 1965
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Glucose Concentrations

  26 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

subcutaneous daily injection

Drug: placebo

liraglutide

ACTIVE COMPARATOR

subcutaneous daily injection

Drug: liraglutide

Interventions

liraglutide DRUG

liraglutide

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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)

You may not qualify if:

• )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.

Sponsors & Collaborators

• University at Buffalo: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (2)

diabetes endocrinology center of WNY

Buffalo, New York, 14215, United States

Location

Diabetes Endocrinology Research Center of WNY

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Dr. Paresh Dandona
• Organization: University at Buffalo

dandona@buffalo.edu

716-535-1850

Study Officials

• Paresh Dandona, MBBS

  SUNY UB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: February 1, 2018
• Last Updated: December 17, 2019
• Results First Posted: December 17, 2019

Record last verified: 2019-12

Locations

US (2)