NCT02470039

Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare NNC0123-0000-0338 (insulin-338) in a tablet formulation and insulin glargine in combination with metformin with or without DPP-4 inhibitor in subjects with type 2 diabetes currently treated with oral antidiabetic therapy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 diabetes

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_2 diabetes

Geographic Reach
1 country

2 active sites

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

May 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2015

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

7 months

First QC Date

May 29, 2015

Last Update Submit

March 13, 2019

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change in fasting plasma glucose (FPG)

    Week 0, Week 8

Secondary Outcomes (3)

  • Change from baseline in 10-points plasma glucose profile

    Week 0, Week 8

  • Number of treatment emergent hypoglycaemic episodes

    From start of treatment until Visit 14 (Day 68)

  • area under the serum insulin concentration-time curve

    During one dosing interval (0 to 24 hours) at steady state (Day 56)

Study Arms (2)

Oral insulin 338 and subcutaneous placebo

EXPERIMENTAL
Drug: insulin 338 (GIPET I)Drug: placebo

Subcutaneous insulin glargine and oral placebo

ACTIVE COMPARATOR
Drug: insulin glargineDrug: placebo

Interventions

insulin 338 (GIPET I)DRUG

Oral administered once daily in combination with metformin with or without DPP-4 inhibitor

Oral insulin 338 and subcutaneous placebo
insulin glargineDRUG

Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor

Subcutaneous insulin glargine and oral placebo
placeboDRUG

Administered once daily

Oral insulin 338 and subcutaneous placeboSubcutaneous insulin glargine and oral placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18-70 years (both inclusive) at the time of signing informed consent
  • Body mass index of 25.0-40.0 kg/m\^2 (both inclusive)
  • Subject diagnosed (clinically) with type 2 diabetes mellitus for at least 180 days prior to the day of screening
  • Insulin naïve subject; however, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes

You may not qualify if:

  • Known or suspected hypersensitivity to the trial products or related products
  • Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
  • Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Mainz, 55116, Germany

Location

Novo Nordisk Investigational Site

Neuss, 41460, Germany

Location

Related Publications (1)

  • Halberg IB, Lyby K, Wassermann K, Heise T, Zijlstra E, Plum-Morschel L. Efficacy and safety of oral basal insulin versus subcutaneous insulin glargine in type 2 diabetes: a randomised, double-blind, phase 2 trial. Lancet Diabetes Endocrinol. 2019 Mar;7(3):179-188. doi: 10.1016/S2213-8587(18)30372-3. Epub 2019 Jan 21.

    PMID: 30679095RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 12, 2015

Study Start

June 1, 2015

Primary Completion

December 31, 2015

Study Completion

December 31, 2015

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

DE(2)