DiabetesPhase 2NCT02470039
Trial to Compare NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
A Phase 2 study testing insulin 338 (GIPET I) and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- insulin 338 (GIPET I) and insulin glargine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jun 2015to 31 Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Novo Nordisk Investigational Site
Mainz, 55116
Novo Nordisk Investigational Site
Neuss, 41460
About this study
Official title: An 8-week Randomised, Double-blind, Parallel, Multiple Dose Trial Comparing NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
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
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- insulin 338 (GIPET I), insulin glargine, placebo
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin 338 (GIPET I)Drug
Oral administered once daily in combination with metformin with or without DPP-4 inhibitor
insulin glargineDrug
Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor
placeboDrug
Administered once daily
| Study group | Role | What they receive |
|---|---|---|
| Oral insulin 338 and subcutaneous placebo | Experimental | Not described Receives: Drug: insulin 338 (GIPET I); Drug: placebo |
| Subcutaneous insulin glargine and oral placebo | Active comparator | Not described Receives: Drug: insulin glargine; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting plasma glucose (FPG)
Measured: Week 0, Week 8
Secondary outcomes (3)
Change from baseline in 10-points plasma glucose profile
Measured: Week 0, Week 8
Number of treatment emergent hypoglycaemic episodes
Measured: From start of treatment until Visit 14 (Day 68)
area under the serum insulin concentration-time curve
Measured: During one dosing interval (0 to 24 hours) at steady state (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study start1 Jun 2015
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470039
- Sponsor's protocol ID
- NN1953-4163
- Other IDs
- 2014-002716-16, U1111-1158-3620, 2014
- Status last verified
- Mar 2019
- First submitted
- 29 May 2015
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 30679095
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week Randomised, Double-blind, Parallel, Multiple Dose Trial Comparing NNC0123-0000-0338 in a Tablet Formulation and Insulin Glargine in Subjects With Type 2 Diabetes Currently Treated With Oral Antidiabetic Therapy
- ClinicalTrials.gov ID
- NCT02470039
- Acronym / sponsor ID
- NN1953-4163
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral insulin 338 and subcutaneous placebo | Experimental | Drug: insulin 338 (GIPET I), Drug: placebo |
| Subcutaneous insulin glargine and oral placebo | Active comparator | Drug: insulin glargine, Drug: placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| insulin 338 (GIPET I)Oral administered once daily in combination with metformin with or without DPP-4 inhibitor | Drug | Oral insulin 338 and subcutaneous placebo |
| insulin glargineInjected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor | Drug | Subcutaneous insulin glargine and oral placebo |
| placeboAdministered once daily | Drug | Oral insulin 338 and subcutaneous placebo, Subcutaneous insulin glargine and oral placebo |
Primary outcome
Change in fasting plasma glucose (FPG)
Time frame: Week 0, Week 8
3 secondary outcomes
Change from baseline in 10-points plasma glucose profile
Time frame: Week 0, Week 8
Number of treatment emergent hypoglycaemic episodes
Time frame: From start of treatment until Visit 14 (Day 68)
area under the serum insulin concentration-time curve
Time frame: During one dosing interval (0 to 24 hours) at steady state (Day 56)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Results publication: PubMed 30679095Halberg 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing insulin 338 (GIPET I) and insulin glargine in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting plasma glucose (FPG) (time frame: Week 0, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02470039, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.