Phase 3 · Liraglutide

NCT01937598 trial results

Antidiabetic Effects of Adding a DPP-4 Inhibitor (Sitagliptin) to Pre-Existing Treatment With an Incretin Mimetic (Liraglutide) in Patients With Type 2 Diabetes Treated With Metformin

Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC) ([mg*min/dL]), 0 to 300 min post mixed meal test. Sitagliptin: 5678; Placebo: 5557.

Participants
16
Status
completed
Completed
2015-06
Sponsor
Michael A. Nauck

As posted on ClinicalTrials.gov (NCT01937598), updated at source Jan 30, 2017. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01937598 measured first

Incremental Area Under the Plasma Glucose (BG) Concentration-time Profile (AUC)[mg*min/dL] · 0 to 300 min post mixed meal test · mean
Sitagliptinn=16Placebon=16
5678(329)5557(547)
Side effects by arm

Side effects in NCT01937598

Percent of participants affected, up to 32 days after randomisation. The most common events the registry lists.

EventSitagliptinPlacebo
Any serious event0%0%
Headache12.5%12.5%
Nausea6.3%0%
asympomatic hyppglycaemia6.3%0%
Secondary outcomes

What else it measured

AUC Plasma Glucosemmol/l*min · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks) · mean
Sitagliptinn=16Placebon=16
315.4(18.3)308.7(30.4)
AUC Insulinnmol/l*min · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks) · mean
Sitagliptinn=16Placebon=16
45.8(7.9)42.6(6.6)
AUC C-peptidenmol/l*min · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks) · mean
Sitagliptinn=16Placebon=16
171.5(16.5)159.2(17.3)
AUC Glucagonpmol/l*min · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks) · mean
Sitagliptinn=16Placebon=16
6933(1056)7004(1124)
AUC Total GLP-1pmol/l*min · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks) · mean
Sitagliptinn=16Placebon=16
748(115)1143(218)
AUC Total GIPpmol/l*min · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks) · mean
Sitagliptinn=16Placebon=16
6242(645)7523(548)
AUC Active GLP-1pmol/l*min · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks) · mean
Sitagliptinn=16Placebon=16
607.9(97.1)418.4(75.6)
AUC Active GIPpmol/l*min · Approximately 6 weeks (range 9 - 60 days / 8.5 weeks) · mean
Sitagliptinn=16Placebon=16
6270(441)3496(623)
The trial

How NCT01937598 was run

Objectives: To quantify differences in control of glycemia (primary objective) and the secretion of endogenous incretin hormones (secondary objective) comparing sitagliptin or placebo added to pre-existing therapy with liraglutide and metformin

  • Sitagliptin, then Placebo
  • Placebo, then Sitagliptin
Who could join the trial

Inclusion Criteria: * Signed \& dated written informed consent * Male \& female subjects with a diagnosis of type 2 diabetes mellitus according to ADA criteria at least 4 months prior to screening * Medical history without major pathology (with the exception of type 2 diabetes) as judged by the investigator * On a stable regimen of metformin for at least 1 month and liraglutide 1.2 mg for at least 1 week at the time-point of randomisation. * Age: 25 - 75 years, both inclusive * Body mass index (BMI): 22 - 40kg/m\^2, both inclusive * HbA1c ≥ 6.5 and ≤ 8.5% (≥ 7.0 and ≤ 8.5% for patients without previous liraglutide treatment) * Female must be post-menopausal, surgically sterilized or practicing an effective birth control Exclusion criteria * Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis * Current or previous treatment with insulin therapy (except for treatment at diabetes' diagnosis, within a clinical trial, for surgical procedures or during an acute illness, and no insulin administration within the 6 months before screening) * Treatment with any hypoglycaemic medication other than metformin and liraglutide within one month prior to screening * Known of diabetic gastroparesis and / or prokinetic therapy * Subjects that underwent surgery of the upper gastrointestinal tract * Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective, medically approved birth control methods * Any severe medical or surgical history of conditions likely to confound study assessments or study endpoints, for example but not limited to haemoglobinopathies, inflammatory bowel disease, cystic fibrosis, bariatric surgery and/or any surgery shortening the intestine, history of lactose intolerance, lactose- or glucose-galactose-malabsorption * A suspicion of medullary thyroid cancer or a multiple endocrine neoplasia * A personal or family history of medullar thyroid cancer or a multiple endocrine neoplasia * Serious and/or unstable coronary heart disease (unstable angina, myocardial infarction within the preceding 6 months), congestive heart failure of New York Heart Association Class III or worse (severe limitation of physical activity; physical activity of low intensity resulting in fatigue, palpitation, or dyspnoea), second/third degree heart block, superior vena cava syndrome, uncontrolled hypertension, history of congenital QT-syndrome within family, history of stroke (within the preceding 6 months) or serious peripheral vascular disease * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) that is symptomatic or requires treatment (grade 3), left bundle branch block, or asymptomatic sustained ventricular tachycardia are not allowed * Marked diabetic complications: severe...

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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