NCT00411411

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at below P25 for phase_3 type-2-diabetes

Timeline
Completed

Started Feb 2007

Typical duration for phase_3 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

August 13, 2014

Completed
Last Updated

August 13, 2014

Status Verified

July 1, 2014

Enrollment Period

2 years

First QC Date

December 13, 2006

Results QC Date

May 19, 2014

Last Update Submit

July 21, 2014

Conditions

Type 2 Diabetes

Keywords

GLP-1GIPIncretin hormonesDPP-IV inhibitorHyperglycaemic clampMeal test

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    12 weeks

Secondary Outcomes (1)

  • Examination of GLP-2, Somatostatin, Glucagon, Peptide-YY and Two Glycaemic Control Parameters (HbA1c and Fasting Plasma Glucose)

    12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo treatment, administered as tablets.

Drug: Placebo

Januvia

EXPERIMENTAL

Active treatment

Drug: Januvia

Interventions

JanuviaDRUG

200 mg t.i.d

Also known as: Sitagliptin
Januvia
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Related Publications (1)

  • Aaboe K, Akram S, Deacon CF, Holst JJ, Madsbad S, Krarup T. Restoration of the insulinotropic effect of glucose-dependent insulinotropic polypeptide contributes to the antidiabetic effect of dipeptidyl peptidase-4 inhibitors. Diabetes Obes Metab. 2015 Jan;17(1):74-81. doi: 10.1111/dom.12395. Epub 2014 Oct 26.

    PMID: 25243647DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Dr. Kasper Aaboe
Organization
Gentofte University Hospital
kasper@dadlnet.dk
+4522170200

Study Officials

  • Kasper Aaboe, MD

    Gentofte University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 13, 2006

First Posted

December 14, 2006

Study Start

February 1, 2007

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

August 13, 2014

Results First Posted

August 13, 2014

Record last verified: 2014-07

Locations

DK(1)