Primary outcome
What NCT01784965 measured first
| Placebon=27 | Liraglutiden=24 |
|---|---|
| -3.3(-4.1 to -2.5) | -6.8(-7.8 to -5.9) |
Phase 3 · Liraglutide
NCT01784965 trial results
Addition of a Glucagon-like Peptide-1 to a Calorie Restricted Diet Augments Weight Loss and Decreases Risk of Type 2 Diabetes and Cardiovascular Disease.
Change in Weight Reported at 14 Weeks (kg), Baseline and 14 weeks. Placebo: -3.3; Liraglutide: -6.8.
- Participants
- 69
- Status
- completed
- Completed
- 2012-12
- Sponsor
- Stanford University
As posted on ClinicalTrials.gov (NCT01784965), updated at source Apr 21, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT01784965
Percent of participants affected. The most common events the registry lists.
| Event | Liraglutide | Placebo |
|---|---|---|
| Any serious event | 22.9% | 0% |
| Decided to withdraw | 0% | 18.2% |
| protocol deviation | 2.9% | 0% |
| elective back surgery | 2.9% | 0% |
| Family issues | 2.9% | 0% |
Secondary outcomes
What else it measured
| Placebon=27 | Liraglutiden=24 |
|---|---|
| -7.3(-17 to 2) | 34(21 to 48) |
| Placebon=27 | Liraglutiden=24 |
|---|---|
| 2.8(35.9) | -57.5(44.2) |
The trial
How NCT01784965 was run
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.
- placebo: Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
- liraglutide: Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo
Who could join the trial
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
Published papers
Papers from NCT01784965
- 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.
- 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.
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
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