NCT02089438

Brief Summary

Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and islet hormones. The study examines this in relation to breakfast, lunch and dinner over an entire 24h study period by the use of three different DPP-4 inhibitors and placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4 type-2-diabetes

Timeline
Completed

Started May 2014

Typical duration for phase_4 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

March 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

3.1 years

First QC Date

March 14, 2014

Last Update Submit

August 22, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Postprandial glucose

    The area under the 180 min curves for plasma glucose after each meal

    180 min

Secondary Outcomes (2)

  • Postprandial insulin and glucagon

    180 min

  • Postprandial glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP)

    180 min

Study Arms (3)

Saxagliptin

EXPERIMENTAL

Ssaxagliptin is given before breakfast

Drug: Saxagliptin

´Sitagliptin

EXPERIMENTAL

Sitagliptin is given before breakfast

Drug: Sitagliptin

Vildagliptin

EXPERIMENTAL

Vildagliptin is given before breakfast

Drug: Vildagliptin

Interventions

SaxagliptinDRUG

Saxagliptin (5 mg) is given before breakfast

Also known as: Onglyza
Saxagliptin
VildagliptinDRUG

Vildagliptin (50mg) is given before breakfast and dinner

Also known as: Galvus
Vildagliptin
SitagliptinDRUG

Sitagliptin (100 mg) is given before breakfast

Also known as: Januvia
´Sitagliptin

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ongoing treatment with life style adjustment including diet and exercise regimen together with metformin as oral antidiabetic . Metformin therapy should be stable the last three months
  • Age 40-75 years
  • HbA1c 52-80 mmol/mol (inclusive)
  • BMI: 20-40 kg/m2
  • Written informed consent has been given
  • Capability and willingness to participate in the whole study

You may not qualify if:

  • Liver disease (K70-77 in ICD10) or liver enzymes three times above upper reference range
  • Diabetic nephropathy (GFR \< 30 mL/min/1.73 m2 or albuminuria) or other causes of renal disease
  • Proliferative diabetic retinopathy
  • Treatment with any glucose-lowering medication except metformin
  • Previous myocardial infarction, coronary heart disease or instable angina pectoris in the last 6 months.
  • Symptomatic heart failure (NYHA class II-III)
  • Previous surgery on the gastrointestinal tract
  • Larger surgical intervention during the last 12 weeks
  • Female subject who are pregnant or breast feeding
  • Women of child bearing potential not using a highly effective method of birth control
  • Treatment with oral steroids, thiazide diuretics, digoxin or growth hormone
  • Hypersensitivity to the active substances of to any of the excipients
  • Participation in another study the last 4 weeks
  • Smoker
  • Paracetamol intolerance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Department

Lund, 22185, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

saxagliptinVildagliptinSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTriazolesAzolesPyrazines

Study Officials

  • Bo Ahrén, MD, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 17, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

SE(1)