Liraglutide Effect on Beta-cell Function in C-peptide Positive Type 1 Diabetes

NCT02617654 | Completed Phase 2

• 1 other identifier: U1111-1166-6923
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Recent studies show that many Type 1 diabetes patients have remaining endogenous insulin production, albeit at low levels. Finding means to increase this production would be of tremendous interest, since residual C-peptide concentrations \>0.1 nmol/l previously have been shown to markedly lower HbA1c, decrease blood glucose fluctuations and diminish the risk of ketoacidosis. It also substantially reduces the risks of severe hypoglycemic events and late complications. Liraglutide may through its incretin effect directly potentiate beta-cell function, but also holds the potential to be mitogenic for these cells. The hypothesis of the present trial is that treatment with liraglutide will not only have a direct effect on beta-cell function, which is more or less immediately observed, but also progressively improve C-peptide concentrations over time.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• The effect of 52 weeks of treatment with liraglutide 1.8 mg/day, compared to placebo, on stimulated C-peptide concentrations in patients with long-standing type 1 diabetes and residual insulin production

  The Area Under the Curve (AUC) change in plasma C-peptide concentration in response to a standardized mixed meal tolerance test (MMTT) during one year of liraglutide treatment (1.8 mg/day)

  52 weeks

Secondary Outcomes (17)

• Change in C-peptide between 6 and 52 weeks of study

  52 weeks

• Change in C-peptide between after and prior to treatment with liraglutide 1.8 mg

  52 weeks

• Change in HbA1c between before and at end of liraglutide (1.8 mg) treatment

  52 weeks

• Change in HbA1c between 6 and 52 weeks of study

  52 weeks

• Change in HbA1c between after and prior to treatment with liraglutide 1.8 mg

  52 weeks

Study Arms (2)

Liraglutide treatment

ACTIVE COMPARATOR

Liraglutide treatment in the dose of 1.8 mg daily for 52 weeks

Drug: Liraglutide

Placebo treatment

PLACEBO COMPARATOR

Treatment with placebo once daily for 52 weeks

Drug: Placebo for liraglutide

Interventions

Liraglutide DRUG

Treatment with liraglutide for 52 weeks

Liraglutide treatment

Placebo for liraglutide DRUG

Placebo for liraglutide. Treatment once daily for 52 weeks

Placebo treatment

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent for participation of the study, given before undergoing any study-specific procedures.
• years of age (age interval inclusive of both the ends). Both males and females are eligible for the study
• Clinical diagnose of T1D
• Five or more years duration of disease
• HbA1C between 45 and 75 mmol/mol
• Fasting plasma C-peptide concentration \>1.5 pmol/l.

You may not qualify if:

• Inability to provide informed consent
• Mental incapacity
• Unwillingness or language barrier precluding adequate understanding or cooperation
• Ongoing or planned pregnancy within the next 12 months
• Inadequate or no use of contraceptives
• Ongoing breast feeding
• Known sight-threatening retinopathy
• Creatinine clearance \<60 ml/min
• Life-threatening cardiovascular disease
• History of drug/alcohol abuse
• Known or suspected allergy to trial product or related product
• Recurrent assisted hypoglycemias
• Taking oral anti-diabetic therapies or any other concomitant medication which may interfere with glucose regulation other than insulin
• Uncontrolled hypertension (180/105 mmHg or above)
• History of acute or chronic pancreatitis

Sponsors & Collaborators

• Per-Ola Carlsson: lead

Study Sites (1)

Uppsala University Hospital

Uppsala, SE-75185, Sweden

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

Study Officials

• Per-Ola Carlsson, MD, PhD

  Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, senior consultant

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: December 1, 2015
• Study Start: November 1, 2015
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-11

Locations

SE (1)