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NCT04228484: GA-16
The Insulin Response to the Gut Hormone GIP After Near-normalisation of Plasma Glucose in Patients With Type 2 Diabetes
NA trial testing Placebo in Type2 Diabetes in 15 participants. Completed in 1 October 2022.
4 June 2021
Quick facts
| Lead sponsor | University Hospital, Gentofte, Copenhagen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | triple |
| Primary purpose | basic science |
| Enrollment | 15 |
| Start date | 7 January 2020 |
| Primary completion | 4 June 2021 |
| Estimated completion | 1 October 2022 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Placebo
- GIP receptor antagonization
Conditions studied
- Type2 Diabetes — all drugs for Type2 Diabetes →
Sponsor
University Hospital, Gentofte, Copenhagen
Who can join
18 and older, any sex, with Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The investigators hypothesise that the insulinotropic effect of endogenous GIP is improvable in patients with type 2 diabetes after three weeks of near-normalisation of plasma glucose. To test this hypothesis, a randomised, placebo-controlled, double-blinded, crossover study employing a GIP receptor antagonist, will be carried out. Fifteen overweight (body mass index (BMI) \> 25 kg/m2) dysregulated (HbA1c \>/= 59 mmol/mol and treatment with metformin or \>53 mmol/mol and treatment with metformin + add/on) patients with type 2 diabetes will attend two experimental days followed by a three-week-four-week period of plasma glucose near-normalisation (achieved by standard treatment of type 2-diabetes), followed by another two experimental days. On experimental days, patients will receive an infusion of GIP receptor antagonist or placebo during a 75 g oral glucose tolerance test. The primary endpoint is changes in levels of C-peptide divided by changes in levels of plasma glucose and secondary endpoints include changes in circulating levels of C-peptide, insulin, glucose, GIP, glucagon-like peptide 1 (GLP-1), glucagon and markers of bone turnover as well as indices of beta cell function. Furthermore, gastric emptying rate will be assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04228484
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University Hospital, Gentofte, Copenhagen trials
Trials by the same sponsor.
- NCT07171723 — Studying the Influence of LEAP2 on Integrated Endocrine Control of Eating During Semaglutide Treatment · Phase 1, PHASE2 · recruiting
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- NCT06787001 — Understanding How Gut and Brain Barriers Are Linked to Inflammation in Obesity · completed
- NCT06881459 — The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04228484 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Gentofte, Copenhagen
- Last refreshed: 4 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04228484.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing