Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT01784965Other id17394

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 69 participants (actual)
Sponsor: Stanford University · Other
Design: Randomized · Triple masking
Countries: Not stated
Start: Dec 2009
Primary completion: Dec 2012
Completion: Dec 2012
First posted: 6 Feb 2013 (estimated)
Last update posted: 21 Apr 2017
Conditions: Pre-diabetes · Older Adults

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20092010201120122013

Ph 3
Liraglutide and a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and CVD.
NCT01784965
Dec 2009 to Dec 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

liraglutideDrug
PlaceboDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in Weight Reported at 14 Weeks
Time frame · Baseline and 14 weeks
Registry description
Change in weight with caloric restriction plus liraglutide vs. caloric restriction and placebo over 14 weeks.

Secondary outcomes(2)

Glucose-stimulated Insulin Secretion in Insulin AUC, Pmol/1x 4H
Time frame · Baseline, 14 weeks
Registry description
Absolute change in glucose-stimulated insulin secretion (GS-IS) associated with caloric restriction plus liraglutide vs. caloric restriction and placebo at 14 weeks
Insulin Resistance in the Liraglutide vs.Placebo Group After Calorie Restriction
Time frame · Baseline, 14 weeks
Registry description
Mean (+/- SD) change in insulin resistance associated with caloric restriction plus liraglutide vs. caloric restriction and placebo.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 14 weeks

Change in Weight Reported at 14 Weeks

Group	Value (kg)
Placebo	-3.3
Liraglutide	-6.8

Secondary and other outcome results(2)

Secondary outcomeMean· Baseline, 14 weeks

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

Group	Value (pmol/l x4 h)
Placebo	-7.3
Liraglutide	34

Secondary outcomeMean· Baseline, 14 weeks

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

Group	Value (mg/dL)	Spread
Placebo	2.8	35.9
Liraglutide	-57.5	44.2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
LiraglutideIntolerable gastrointestinal side effects 3/35 injection site reaction 2/35 pneumonia 1/35 gallstone 1/35 fall 1/35	–	8 / 35	3 / 35
Placebo0/33 0/33 0/33 0/33 0/33	–	0 / 33	6 / 33

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2014

8 results

Pancreatic beta cell function following liraglutide-augmented weight loss in individuals with prediabetes: analysis of a randomised, placebo-controlled study.

Kim et al. 2014Diabetologiacited by 32

PMID 24326527PMC5072364DOI 10.1007/s00125-013-3134-3PUB-24326527

Rights unknown8 results

Source link See results (8)

Indexing hint: Randomized controlled trial · 2013

8 results

Benefits of liraglutide treatment in overweight and obese older individuals with prediabetes.

Kim et al. 2013Diabetes carecited by 82

PMID 23835684PMC3781545DOI 10.2337/dc13-0354PUB-23835684

Free to read · publisher termsCC BY-NC-ND8 results

Read at source See results (8)

Eligibility

Who could join, as posted.

Sex: All
Age: from 40 Years up to 70 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: IFG, or IGT BMI 27.0-37.0 kg/m2 Exclusion Criteria: 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

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