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NCT01278485: NEEDS
Naturalistic Evaluation of Hypoglycemic Events in Diabetic Subjects
trial testing Sulphonylurea in Type 2 Diabetes Mellitus in 726 participants. Completed in 1 June 2012.
1 June 2012
Quick facts
| Lead sponsor | Merck Sharp & Dohme LLC |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 726 |
| Start date | 1 May 2011 |
| Primary completion | 1 June 2012 |
| Estimated completion | 1 June 2012 |
Drugs / interventions tested
- Sulphonylurea — full drug profile →
- Metformn — full drug profile →
Conditions studied
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Merck Sharp & Dohme LLC — full company profile →
Who can join
30 and older, any sex, with Type 2 Diabetes Mellitus. 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.
-
Number of Participants Experiencing Hypoglycemic Episodes in the 6 Months Prior to Enrollment
Time frame: Up to 6 Months Prior to Enrollment
The participant experience of low blood sugar (hypoglycemia) questionnaire was used to evaluate participants' experience of hypoglycemia during the previous 6 months. Participants were asked to record whether they experienced hypoglycemia symptoms (yes/no) and to record the severity of those symptoms as mild, moderate, severe, or very severe. -
Number of Participants Experiencing Mild, Moderate, Severe, or Very Severe Hypoglycemic Episodes in the 6 Months Prior to Enrollment
Time frame: Up to 6 Months Prior to Enrollment
At the time of enrollment, participants were asked to rate their hypoglycemic episodes in the last 6 months as mild, moderate, severe, or very severe. Participants were able to select more than one category. -
Number of Participants With Hemoglobin A1c <7.0% at the Time of Enrollment
Time frame: Day of Enrollment
Participant serum samples were collected after an overnight fast to determine the hemoglobin A1c level. Hemoglobin A1c is a measure of the percentage of glycated hemoglobin in the blood and provides an indication of participant blood glucose control in the 2 to 3 months prior to the evaluation.
Sponsor's own description
This is a multicenter, observational, retrospective and cross-sectional study to be conducted in a cohort of consecutively selected participants with type 2 diabetes mellitus (T2DM) who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy by their cardiologist, nephrologist, or family practice doctor for at least 6 months prior to study enrollment. The purpose of the study is to assess treatment patterns, goal attainment rates, long-term diabetes complication rates, and frequency and severity of hypoglycemic episodes among T2DM participants treated in cardiology, nephrology and family practice settings.
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 NCT01278485
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 2 Diabetes Mellitus
Currently open trials in the same condition.
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- NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · 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
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT01278485 (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: 17 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/NCT01278485.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing