Study of Liraglutide in Individuals With Type 2 Diabetes Using Insulin

NCT01628445 | Terminated Phase 3

• 1 other identifier: U1111-1126-3937
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Liraglutide is a GLP1 agonist used in the treatment of Type 2 diabetes and is is asociated with improved blood glucose control, weight loss and low rates of hypoglycemia when used alone or in combination with metformin. Liraglutide has not been extensively tested in people with type 2 diabetes who are taking relatively large doses of insulin (\>50 U/day). Often these patients are insulin resistant and despite using large doses of insulin are not able to achieve glucose targets. The rationale for this study is to assess if the addition of liraglutide in addition to usual care versus placebo can improve blood glucose levels in people not achieving a target HbA1C of less than 7.0%.

Conditions

Type 2 Diabetes

Keywords

Diabetes; Insulin

Outcome Measures

Primary Outcomes (1)

• Change in A1c

  Baseline to 24 wks

Secondary Outcomes (12)

• Percentage of patients experiencing hypoglycemia

  Baseline and 24 weeks

• Change in Systolic Blood pressure

  Baseline and 24 weeks

• Change in diastolic blood pressure

  Baseline and 24 weeks

• Change in waist circumference

  Baseline and 24 weeks

• Change in body weight

  Baseline and 24 weeks

Study Arms (2)

liraglutide

ACTIVE COMPARATOR

liraglutide 1.8 mg injected once daily

Drug: liraglutide

Placebo injection

PLACEBO COMPARATOR

Drug: placebo injection

Interventions

liraglutide DRUG

liraglutide titrated to 1.8 mg sc daily

Also known as: Victoza

liraglutide

placebo injection DRUG

placebo injected sc daily volume equal to active comparator

Also known as: Placebo

Placebo injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• BMI≤45 kg/m2
• A1c ≥7.5% and ≤10.5%

You may not qualify if:

• type 1 diabetes
• symptoms of poorly controlled diabetes
• eGFR \<50 ml/min/1.73m2

Sponsors & Collaborators

• University of Manitoba: lead
• Novo Nordisk A/S: collaborator

Study Sites (1)

Winnipeg Regional Health Authority Health Sciences Centre Winnipeg Diabetes Research Group

Winnipeg, Manitoba, R3E3P4, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus; Insulin Resistance

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

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

Study Officials

• Vincent C Woo, MD FRCPC

  University of Mantioba

  PRINCIPAL INVESTIGATOR

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: Assistant Professor

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: June 26, 2012
• Study Start: August 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

CA (1)