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CompletedNCT00334711Updated Nov 29, 2006

Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations

An interventional study of Sulfonylurea in Diabetes Mellitus, sponsored by Royal Devon and Exeter NHS Foundation Trust. Completed. Per ClinicalTrials.gov, last updated 2006-11-29.

Sponsored by Royal Devon and Exeter NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Sex
All
01

Study summary

The purpose of this study is to investigate whether patients with diabetes due to Kir6.2 mutations can be treated with sulfonylurea medication rather than insulin, and if this is the case to investigate the mechanism for sulfonylurea response.

02

Conditions studied

  • Diabetes Mellitus

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Keywords

  • Permanent Neonatal Diabetes
  • Kir6.2
  • KCNJ11
  • Infancy onset diabetes
  • Sulfonylurea
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 50 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Royal Devon and Exeter NHS Foundation Trust is the lead sponsor of 62 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diabetes due to KCNJ11 (Kir6.2) mutation

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants

Interventions

  • DrugSulfonylurea
06

What researchers measure

Primary outcomes

  1. HbA1c reduction

Secondary outcomes

  1. insulin secretory response to intravenous glucose

  2. insulin secretory response to oral glucose

  3. insulin secretory response to mixed meal (sustacal)

  4. Incidence of Hypoglycemia

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Gloyn AL, Pearson ER, Antcliff JF, Proks P, Bruining GJ, Slingerland AS, Howard N, Srinivasan S, Silva JM, Molnes J, Edghill EL, Frayling TM, Temple IK, Mackay D, Shield JP, Sumnik Z, van Rhijn A, Wales JK, Clark P, Gorman S, Aisenberg J, Ellard S, Njolstad PR, Ashcroft FM, Hattersley AT. Activating mutations in the gene encoding the ATP-sensitive potassium-channel subunit Kir6.2 and permanent neonatal diabetes. N Engl J Med. 2004 Apr 29;350(18):1838-49. doi: 10.1056/NEJMoa032922. Erratum In: N Engl J Med. 2004 Sep 30;351(14):1470. PubMed 15115830 ↗
  • Pearson ER, Flechtner I, Njolstad PR, Malecki MT, Flanagan SE, Larkin B, Ashcroft FM, Klimes I, Codner E, Iotova V, Slingerland AS, Shield J, Robert JJ, Holst JJ, Clark PM, Ellard S, Sovik O, Polak M, Hattersley AT; Neonatal Diabetes International Collaborative Group. Switching from insulin to oral sulfonylureas in patients with diabetes due to Kir6.2 mutations. N Engl J Med. 2006 Aug 3;355(5):467-77. doi: 10.1056/NEJMoa061759. PubMed 16885550 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00334711
Lead sponsor
Royal Devon and Exeter NHS Foundation Trust
Collaborators
Wellcome Trust, Hôpital Necker-Enfants Malades, Haukeland University Hospital
First posted
Jun 8, 2006
Start date
Jan 2004
Completion
Jan 2006
Last update
Nov 29, 2006

Study contacts

Andrew T Hattersley
study director · Peninsula Medical School, Exeter, UK
Ewan R Pearson
principal investigator · Peninsula Medical School, Exeter, UK
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2006. You cannot join it, but the record below documents what was studied.

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