NCT03867656

Brief Summary

Both GLP-2 and GIP reduce the bone resorption (measured as CTX) in healthy persons. In this study, we will investigate wether GLP-2 and GIP is reducing CTX in persons with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Feb 2019

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

Study Start

First participant enrolled

February 26, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2020

Completed
Last Updated

November 4, 2020

Status Verified

November 1, 2020

Enrollment Period

1.3 years

First QC Date

March 5, 2019

Last Update Submit

November 3, 2020

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusBone resorptionBone formationCTXP1NPGLP-2GIPBone turnoverBone remodeling

Outcome Measures

Primary Outcomes (2)

  • CTX

    Bone resorption measured as collagen type 1 C-terminal telopeptide (CTX) in serum.

    -10 minutes to 240 minutes

  • P1NP

    Bone formation measured as procollagen type 1 N-terminal propeptide (P1NP) in serum.

    -10 minutes to 240 minutes

Secondary Outcomes (10)

  • PTH

    -10 minutes to 240 minutes

  • Sclerostin

    -10 min to 240 min.

  • Glucose

    -10 minutes to 240 minutes

  • Insulin

    -10 minutes to 240 minutes

  • C-peptide

    -10 minutes to 240 minutes

  • +5 more secondary outcomes

Study Arms (3)

GLP-2

EXPERIMENTAL

Glucagon-like peptide 2

Other: GLP-2

GIP

EXPERIMENTAL

Glucose-dependent insulinotropic polypeptide

Other: GIP

Placebo

PLACEBO COMPARATOR

Saline

Other: Placebo

Interventions

GLP-2OTHER

GLP-2 injection

GLP-2
GIPOTHER

GIP injection

GIP
PlaceboOTHER

Placebo injection

Placebo

Eligibility Criteria

Age25 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Age 25 to 70 years old.
  • Type 2 diabetes.
  • In Metformin or sulfonylureas

You may not qualify if:

  • Treatment with other antidiabetics
  • Osteopososis or gastrointestinal disease
  • Smoking
  • Long term steroid treatment
  • Weight change more than 3 kg within the last 3 months.
  • Overweight or intestinal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Bone Resorption

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Mette Rosenkilde, MD

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The study is a crossover study with the following interventions: GLP-2, GIP, and placebo.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 5, 2019

First Posted

March 8, 2019

Study Start

February 26, 2019

Primary Completion

June 26, 2020

Study Completion

June 26, 2020

Last Updated

November 4, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)