Phase 3 N=49 Randomized Double-blind Treatment

Long Term Effects of DPP-IV Inhibitor Treatment in Patients With Type 2 Diabetes

Type 2 Diabetes

Bottom Line

View on ClinicalTrials.gov: NCT00411411 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2014

Primary outcome: Primary: the Relative Increase in Meal-induced Total GLP-1 Secretion — 2591; 3959 pM x 120 min

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Januvia (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University Hospital, Gentofte, Copenhagen
Primary completion: Feb 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY the Relative Increase in Meal-induced Total GLP-1 Secretion	2591; 3959	—
PRIMARY Restoration of the Insulinotropic Effect of GIP	17.8; 21.3; 19.7; 30.0	—
SECONDARY Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose)	—	—

Summary

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.

Eligibility Criteria

Inclusion criteria

Type 2 diabetes diagnosed according to and in accordance with the WHO criteria
Metformin treatment of ≥ 1 gram
7,5 % ≤ HbA1c ≤ 10%
Age > 18
BMI ≥ 25 kg/m2
Informed consent
Contraception, if appropriate

Exclusion criteria

Proliferating retinopathy
Uremia, end stage renal disease, diabetic nephropathy or any other cause of impaired renal function with s-creatinine > 130 µM and/or albuminuria (>300 mg/day)
Liver disease with ALAT and/or ASAT > 2 x normal value
Complicated coronary artery disease, NYHA group III and IV
Positive screening for islet cell auto antibodies and/or GAD-65 auto antibodies
Occurrence of type 1 diabetes in first degree relatives
Anaemia
Pregnancy and/or breast feeding
Treatment with medication affecting insulin secretion
non-compliance

Withdrawal criteria

The subject may withdraw at will at any time
Pregnancy discovered during the trial
Severe illness
Unacceptable side effects
If self-measured fasting plasma glucose on three consecutive days exceeds 15 mM, the result is repeated in an immediately scheduled visit, and no treatable intercurrent cause for the hyperglycaemia can be found.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00411411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.