Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.

NCT01784965 | Completed Phase 3 Results

• 1 other identifier: 17394
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to evaluate the hypothesis that the addition of liraglutide, a long-acting glucagon-like peptide 1 (GLP-1) analogue, to a calorie-restricted diet will lead to greater weight loss than will a calorie-restricted diet alone in subjects who are older (50 to 60 years of age), overweight/obese, and prediabetic. These individuals have been selected for study because they are at greatly increased risk to develop type 2 diabetes (2DM) and cardiovascular disease (CVD), and it is hypothesized that the addition of liraglutide to a calorie-restricted diet will significantly decrease risk of these adverse outcomes. There is considerable evidence that GLP-I compounds, including liraglutide, improve glycemic control in patients with manifest 2DM. However, there is relatively little information as to the potential utility of these compounds in nondiabetic individual at greatly increased risk of 2DM and CVD. This research proposal is aimed at providing some of this information by quantifying the effects of liraglutide, a long-acting GLP-1 analogue, on weight loss, insulin secretion, insulin action, and multiple CVD risk factors in a very high risk group-older, overweight/obese, prediabetic individuals. Furthermore, by using specific methods, not surrogate estimates, and avoiding the confounding effects of glucotoxicity, it will be possible to gain new insights into the effects of GLP-1 on insulin secretion and insulin action.

Conditions

Pre-diabetes; Older Adults

Outcome Measures

Primary Outcomes (1)

• Change in Weight Reported at 14 Weeks

  Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.

  Baseline and 14 weeks

Secondary Outcomes (2)

• Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H

  Baseline, 14 weeks

• Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction

  Baseline, 14 weeks

Study Arms (2)

placebo

PLACEBO COMPARATOR

Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo

Drug: Placebo

liraglutide

ACTIVE COMPARATOR

Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo

Drug: liraglutide

Interventions

liraglutide DRUG

Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.

Also known as: Victoza

liraglutide

Placebo DRUG

Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.

placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• IFG, or IGT BMI 27.0-37.0 kg/m2

You may not qualify if:

• DM, CAD, severe anemia, kidney or liver disease, hx of pancreatitis, gallstones, ETOH abuse, personnel or family history of medullary thyroid carcinoma or MEN-2

Sponsors & Collaborators

• Stanford University: lead

Related Publications (2)

• Kim SH, Liu A, Ariel D, Abbasi F, Lamendola C, Grove K, Tomasso V, Reaven G. Pancreatic beta cell function following liraglutide-augmented weight loss in individuals with prediabetes: analysis of a randomised, placebo-controlled study. Diabetologia. 2014 Mar;57(3):455-62. doi: 10.1007/s00125-013-3134-3. Epub 2013 Dec 11.

  PMID: 24326527 DERIVED

• Kim SH, Abbasi F, Lamendola C, Liu A, Ariel D, Schaaf P, Grove K, Tomasso V, Ochoa H, Liu YV, Chen YD, Reaven G. Benefits of liraglutide treatment in overweight and obese older individuals with prediabetes. Diabetes Care. 2013 Oct;36(10):3276-82. doi: 10.2337/dc13-0354. Epub 2013 Jul 8.

  PMID: 23835684 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Major limitation: the experimental groups were relatively small. In addition, 31% of individuals randomized to liraglutide discontinued participation. Other studies suggest tolerance of GLP-1 receptor agonists may vary by population characteristics.

Results Point of Contact

• Title: Gerald Reaven, Professor Emeritus
• Organization: Stanford Universtiy

greaven@stanford.edu

650-724-3416

Study Officials

• Gerald M Reaven, M.D.

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Emeritus

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 21, 2017
• Results First Posted: April 21, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share