Diabetes MellitusNCT00334711
Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations
A study testing Sulfonylurea in people with Diabetes Mellitus, run by Royal Devon and Exeter NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Sulfonylurea
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Jan 2006
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes due to KCNJ11 (Kir6.2) mutation
Who cannot join
- None
About this study
Official title: A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Sulfonylurea
- Keywords
- Permanent Neonatal Diabetes, Kir6.2, KCNJ11, Infancy onset diabetes, Sulfonylurea
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SulfonylureaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c reduction
Secondary outcomes (4)
insulin secretory response to intravenous glucose
insulin secretory response to oral glucose
insulin secretory response to mixed meal (sustacal)
Incidence of Hypoglycemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJan 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Hôpital Necker-Enfants Malades, Haukeland University Hospital
- Investigators
- Andrew T Hattersley, Study director, Peninsula Medical School, Exeter, UKEwan R Pearson, Principal investigator, Peninsula Medical School, Exeter, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334711
- Sponsor's protocol ID
- 2003/10/196
- Other IDs
- 97/29/AH/mbs NTNU, Jnr 207/mkd NTNU, CCPPRB Necker GLIDKIR6.2
- Status last verified
- Jun 2006
- First submitted
- 7 Jun 2006
- Last updated
- 29 Nov 2006
- Results posted
- No
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.
PubMed 15115830Pearson 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations
- ClinicalTrials.gov ID
- NCT00334711
- Acronym / sponsor ID
- 2003/10/196
- Conditions
- Diabetes Mellitus
- Keywords
- Permanent Neonatal Diabetes, Kir6.2, KCNJ11, Infancy onset diabetes, Sulfonylurea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Wellcome Trust, Hôpital Necker-Enfants Malades, Haukeland University Hospital
- Study start
- Jan 2004
- Study completion
- Jan 2006
- First posted
- 8 Jun 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetes due to KCNJ11 (Kir6.2) mutation
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Sulfonylurea | Drug | – |
Primary outcome
HbA1c reduction
4 secondary outcomes
insulin secretory response to intravenous glucose
insulin secretory response to oral glucose
insulin secretory response to mixed meal (sustacal)
Incidence of Hypoglycemia
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 29 Nov 2006.
- Background: PubMed 15115830Gloyn 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.
- Results publication: PubMed 16885550Pearson 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.
- Related InfoLink 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.
Andrew T Hattersley study director
Peninsula Medical School, Exeter, UK
Ewan R Pearson principal investigator
Peninsula Medical School, Exeter, UK
Questions about this trial
What is this clinical trial studying?
A study testing Sulfonylurea in people with Diabetes Mellitus, run by Royal Devon and Exeter NHS Foundation Trust.
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 1 inclusion and 1 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 29 Nov 2006. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
HbA1c reduction. 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 NCT00334711, which also lists 2 linked publications.
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 29 Nov 2006.