NCT01152242 is a Phase 1 clinical trial of Isoglycemic Clamp in Diabetes, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT01152242?

NCT01152242 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT01152242?

Interventions in NCT01152242: Isoglycemic Clamp, Comparator: insulin glargine.

Is NCT01152242 still recruiting?

NCT01152242 is currently completed. Last updated 22 July 2015.

Last reviewed 2015-07-22 · How we verify

NCT01152242

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin

Completed Phase 1 Last updated 22 July 2015

What this trial tests

Phase 1 trial testing Isoglycemic Clamp in Diabetes in 36 participants. Completed in 1 May 2012.

Timeline

1 August 2010

Primary endpoint
1 May 2012

1 May 2012

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 August 2010
Primary completion	1 May 2012
Estimated completion	1 May 2012

Drugs / interventions tested

Isoglycemic Clamp — full drug profile →
Comparator: insulin glargine — full drug profile →

Conditions studied

Diabetes — all drugs for Diabetes →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 18 to 45, male only, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
Time frame: Baseline and 30 hours
Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine
Time frame: Baseline and 30 hours

Sponsor's own description

The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.

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:

Other recruiting trials for Diabetes

Currently open trials in the same condition.

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NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity · NA · recruiting
NCT07417865 — ECHO Diabetes FQHC · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01152242 (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 Merck Sharp & Dohme LLC
Last refreshed: 22 July 2015

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/NCT01152242.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing