A Phase 3 interventional study of Januvia and Placebo in Type 2 Diabetes, sponsored by University Hospital, Gentofte, Copenhagen. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-08-13.
Sponsored by University Hospital, Gentofte, Copenhagen · Phase 3, Interventional, and Treatment
We wish to evaluate the effect of long term treatment with a DPP-IV inhibitor on the function of the incretin hormones
Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by DPP-IV inhibitor (Januvia®) treatment significantly ameliorates the impaired secretion and potency of GLP-1 and leads to a restoration of the lost action of GIP.
Background The incretin effect, primarily mediated by the peptide hormones GIP and GLP-1, is known to be impaired in patients with type 2 diabetes, and characterised by reduced GLP-1 secretion and potency and a lack of responsiveness to the insulinotropic effect of GIP. The cause of this defect remains unknown, but exogenous administration of GLP-1 has shown promising results in attempts to restore the incretin effect. Due to rapid degradation of both incretin hormones by the enzyme dipeptidyl-peptidase IV (DPP-IV), treatment strategies now focus on GLP-1 analogues and prevention of hormone degradation through DPP-IV inhibition.
Hypothesis We hypothesize that that a gradual improvement in metabolic control induced by DPP-IV inhibitor (Januvia®) treatment significantly ameliorates the impaired secretion and potency of GLP-1 and leads to a restoration of the lost action of GIP.
Objective To assess the effect of three months treatment with Januvia®, administered as tablets once daily, on metabolic control in metformin treated patients with type 2 diabetes, measured as increases in incretin hormones and insulin secretion.
Efficacy end points Primary efficacy end point in trial part one is the relative increase in meal-induced total GLP-1 secretion after one and twelve weeks of Januvia® treatment.
Primary efficacy end point in part two is restoration of the insulinotropic effect of GIP, measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose after 12 weeks of Januvia® treatment.
Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose)
Design This is a single centre, randomized, double blinded, placebo controlled trial. The trial consists of two parts, each consisting of three months of inhibitor treatment. In each part, 24 patients, recruited from the Diabetes Outpatient Clinic of Gentofte University Hospital, will be randomized to a treatment supplement of either Januvia® or placebo.
Procedures During the trial, patients will be tested with well established procedures. In part one, patients will undergo a standardized meal test and two β-cell secretory capacity tests. In part two, patients will undergo standardized hyperglycaemic GIP, GLP-1 and saline clamps.
Safety The trial has a short time span of only three months. With more than ten visits during this time and regular blood sampling, the patients are well monitored.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 49 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University Hospital, Gentofte, Copenhagen is the lead sponsor of 160 studies on the registry; 9 are open to participants now.
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Exclusion criteria
Withdrawal criteria
Placebo treatment, administered as tablets.
Drug: Placebo
Active treatment
Drug: Januvia
200 mg t.i.d
Also known as: Sitagliptin
Placebo
the Relative Increase in Meal-induced Total GLP-1 Secretion
Patients will be followed for 12 weeks with three meal test examinations; before treatment, after 1 week of treatment and after 12 weeks of treatment. Primary outcome is AUC GLP-1 (pM x 120 as stated).
Time frame: 12 weeks
Restoration of the Insulinotropic Effect of GIP
Restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose. Patients will be followed for 12 weeks with examinations after 1 and after 12 weeks of treatment.
Time frame: 12 weeks
Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose)
Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose). Patients will be followed for 12 weeks with three examinations; before, during and after the treatment
Time frame: 12 weeks
Patients recruited from Jan. 2008 to Dec 2009 through out-patient clinic and advertisement
| Milestone | Placebo | Januvia |
|---|---|---|
| Started | 24 | 25 |
| Completed | 24 | 25 |
| Not completed | 0 | 0 |
Patients will be followed for 12 weeks with three meal test examinations; before treatment, after 1 week of treatment and after 12 weeks of treatment. Primary outcome is AUC GLP-1 (pM x 120 as stated).
| pM x 120 min | Placebo | Januvia |
|---|---|---|
| the Relative Increase in Meal-induced Total GLP-1 Secretion | 2591 ± 358 | 3959 ± 877 |
Restoration of the insulinotropic effect of GIP measured as the relative increase in GIP induced amplification of the late phase insulin secretion (AUC) response to glucose. Patients will be followed for 12 weeks with examinations after 1 and after 12 weeks of treatment.
| pM x 120 min | Placebo | Januvia |
|---|---|---|
| After 1 week | 17.8 ± 3.0 | 21.3 ± 4.3 |
| After 12 weeks | 19.7 ± 3.7 | 30.0 ± 6.2 |
Secondary objectives are examination of GLP-2, somatostatin, glucagon, peptide-YY and two glycaemic control parameters (HbA1c and fasting plasma glucose). Patients will be followed for 12 weeks with three examinations; before, during and after the treatment
Results for this outcome have not been posted.
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | — | — |
| Januvia | — | — | — |
| Age, Categorical(Participants) | Placebo | Januvia | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 25 | 48 |
| >=65 years | 1 | 0 | 1 |
| Age, Continuous(years) | Placebo | Januvia | Total |
|---|---|---|---|
| Mean | 60 (31 to 72) | 60 (39 to 64) | 60 (31 to 72) |
| Sex: Female, Male(Participants) | Placebo | Januvia | Total |
|---|---|---|---|
| Female | 11 | 12 | 23 |
| Male | 13 | 13 | 26 |
| Region of Enrollment(participants) | Placebo | Januvia | Total |
|---|---|---|---|
| Denmark | 24 | 25 | 49 |
The record gives a start of Feb 2007, a primary completion of Feb 2009 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 5 years 6 months after primary completion.
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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sitagliptin
University Hospital, Gentofte, Copenhagen →