Liraglutide in Type 1 Diabetes

NCT01722240 | Completed Phase 3 Results DMC

• 2 other identifiers: 19661R01DK092653-01A1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The glucose lowering effects of GLP-1 agonists are well established in subjects with type 2 diabetes, however, these have not been studied prospectively in subjects with type 1 diabetes. The investigators have, therefore, designed this study to investigate the central hypothesis that in patients with type 1 diabetes, Liraglutide has a glucose lowering effect. A major secondary objective of this study is to elucidate the mechanisms responsible for its glucose lowering effects and those involved in reducing the insulin dose. The specific aims of this proposal are: Hypothesis 1: Treatment with Liraglutide in patients with type 1 diabetes decreases HbA1c, fasting, postprandial and the overall mean glucose concentrations while decreasing the dose of insulin required. Hypothesis 2: Treatment with Liraglutide in patients with type 1 diabetes decreases basal and postprandial glucagon concentrations and increases basal and postprandial C-peptide concentrations. Hypothesis 3: Treatment with Liraglutide in patients with type 1 diabetes delays gastric emptying.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• HbA1c (%)

  HbA1c measured at baseline and after 52 weeks of treatment with Liraglutide or placebo.

  52 Weeks

Secondary Outcomes (2)

• Mean Weekly Glucose Concentrations.

  52 Weeks

• Body Weight

  52 weeks

Study Arms (2)

Liraglutide 1.8mg

ACTIVE COMPARATOR

Daily Injection

Drug: Liraglutide 1.8mg

Placebo

PLACEBO COMPARATOR

Daily Injection

Drug: Placebo

Interventions

Liraglutide 1.8mg DRUG

Liraglutide 1.8mg

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• 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.
• Regularly measuring blood sugars four times daily.
• HbA1c of less than 8.5%.
• Well versed with carbohydrate counting.
• Age 18-75 years.
• BMI 20-40 kg/m2

You may not qualify if:

• Type 1 diabetes for less than 6 months;
• Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks;
• Hepatic disease (transaminase \> 3 times normal) or cirrhosis;
• Renal impairment (serum eGFR \< 30ml/min/1.73m2);
• HIV or Hepatitis B or C positive status;
• Participation in any other concurrent clinical trial;
• Any other life-threatening, non-cardiac disease;
• Use of an investigational agent or therapeutic regimen within 30 days of study.
• history of pancreatitis
• pregnancy
• inability to give informed consent
• history of gastroparesis
• history of medullary thyroid carcinoma or MEN 2 syndrome.

Sponsors & Collaborators

• University at Buffalo: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Diabetes-Endocrinology 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: Division of Endocrinology, Diabetes and Metabolism, State University of New York at Buffalo, 462 Grider St, Buffalo, NY 14215, USA

pdandona@kaleidahealth.org

7169574325

Study Officials

• Paresh Dandona, MBBS, PhD

  Kaleida Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Diabetes-Endocrinology Center of Western NY

Study Record Dates

• First Submitted: November 2, 2012
• First Posted: November 6, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2019
• Study Completion: July 29, 2019
• Last Updated: January 23, 2024
• Results First Posted: January 23, 2024

Record last verified: 2024-01

Locations

US (1)