PregnancyPhase 3GRACESNCT02080377
A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
A Phase 3 study testing Glibenclamide and Insulin in people with Pregnancy and Gestational Diabetes, run by University of Edinburgh at 5 sites in United Kingdom.
Trial summary
The aim of this open label feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Pregnancy, Gestational Diabetes
- What is being tested?
- Glibenclamide and Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Jul 2014to Mar 2016
- Phase
- Phase 3
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women diagnosed with gestational diabetes who fail to achieve "adequate glycaemic control" on maximum tolerated dose metformin
- Inadequate glycaemic control is defined according to the SIGN 116 guidelines.
Who cannot join
- Pregnant women requiring insulin prior to 20 weeks gestation or after 36 weeks gestation.
- Pregnant women not taking at least 500mg metformin daily.
- Patients with suspected Type 1 diabetes mellitus presenting in pregnancy.
- Women with allergies to either glibenclamide or insulin or any of their excipients.
- Women with any contraindications to sulfonylurea therapy.
- Women unable to give informed consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Simpson Centre for Reproductive Health, Royal Infirmary Hospital, Edinburgh
Edinburgh, Lothian, EH16 4SA
Western General Hospital
Edinburgh, Lothian, EH4 2XU
Queen Elizabeth Hospital
Glasgow, Glasgow
Princess Royal Infirmary
Glasgow, Lanarkshire, G31 2ER
St Johns Hospital
Livingston, West Lothian
About this study
The aim of this open label feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This feasibility trial will inform the design of a future substantive multicentre trial to test the hypothesis that combination therapy with glibenclamide and metformin could reduce the number of pregnant women with GDM who require insulin and would be superior to metformin and insulin in terms of acceptability and cost effectiveness.
Women with GDM who have "failed" monotherapy with metformin will be recruited and randomised to either receive glibenclamide (test arm) or standard care with insulin, both in addition to their maximum tolerated dose of metformin. Patients will be recruited from three of the antenatal clinics.
This is a feasibility study in preparation for a large multicentre randomised trial to test the hypothesis that the addition of glibenclamide to metformin (combination therapy) could reduce the number of pregnant women with gestational diabetes mellitus requiring insulin, without compromising glycaemic control or other clinical outcomes. The investigators hypothesise that combination therapy with metformin and glibenclamide is likely to be preferable to metformin and insulin in terms of acceptability and cost.
- Conditions
- Pregnancy, Gestational Diabetes
- Being tested
- Glibenclamide, Insulin
- Keywords
- Pregnancy, Gestational diabetes, Glycaemic control, Metformin
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlibenclamideDrug
InsulinDrug
| Study group | Role | What they receive |
|---|---|---|
| Current Standard Care | Active comparator | Insulin + Metformin Receives: Drug: Insulin |
| Treatment | Active comparator | Glibenclamide + Metformin Receives: Drug: Glibenclamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of women willing to be randomised
- Retention - proportion of women randomised who remain in the study to provide outcomes
- Adherence - proportion of clinicians who adhere to the treatment regimen(s)
Measured: 2 years
Secondary outcomes (6)
Glycaemic control
Safety - number of hypoglycaemic episodes needing treatment, any other adverse events
Measured: 2 weekly
Patient satisfaction
assessed by visual analogue scale
Measured: 36-38 weeks gestation
Clinical outcomes
Change in maternal weight between booking and 36 weeks
Measured: 36 weeks
Clinical outcome
Mode and gestation of delivery.
Measured: 40 weeks
Clinical Outcome
Birthweight centile (adjusted for sex and gestation at birth)
Measured: 40 weeks
Clinical Outcome
Incidence of neonatal hypoglycaemia (defined as any of the following: blood glucose <2.6 mmol/l) in first 48hrs age, or given intravenous glucose or any other drug to increase blood glucose)
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Responsible party
- Sponsor
- Investigators
- Jane E Norman, MD, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080377
- Sponsor's protocol ID
- GRACES
- Other IDs
- 2013-004706-25
- Acronym
- GRACES
- Status last verified
- Dec 2015
- First submitted
- 11 Feb 2014
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Reynolds RM, Denison FC, Juszczak E, Bell JL, Penneycard J, Strachan MWJ, Lindsay RS, Alexander CI, Love CDB, Whyte S, Mackenzie F, Stenson B, Norman JE. Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial. BMC Pregnancy Childbirth. 2017 Sep 22;17(1):316. doi: 10.1186/s12884-017-1505-3.
PubMed 28938877
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study Looking at the Use of Glibenclamide and metfoRmin Versus stAndard Care in gEstational diabeteS
- ClinicalTrials.gov ID
- NCT02080377
- Acronym / sponsor ID
- GRACES / GRACES
- Conditions
- Pregnancy, Gestational Diabetes
- Keywords
- Pregnancy, Gestational diabetes, Glycaemic control, Metformin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Mar 2014 (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 aim of this open label feasibility study is to determine recruitment rates to a randomised trial of glibenclamide compared with insulin (both in addition to maximum tolerated metformin) for the treatment of Gestational Diabetes Mellitus (GDM). This feasibility trial will inform the design of a future substantive multicentre trial to test the hypothesis that combination therapy with glibenclamide and metformin could reduce the number of pregnant women with GDM who require insulin and would be superior to metformin and insulin in terms of acceptability and cost effectiveness.
Women with GDM who have "failed" monotherapy with metformin will be recruited and randomised to either receive glibenclamide (test arm) or standard care with insulin, both in addition to their maximum tolerated dose of metformin. Patients will be recruited from three of the antenatal clinics.
This is a feasibility study in preparation for a large multicentre randomised trial to test the hypothesis that the addition of glibenclamide to metformin (combination therapy) could reduce the number of pregnant women with gestational diabetes mellitus requiring insulin, without compromising glycaemic control or other clinical outcomes. The investigators hypothesise that combination therapy with metformin and glibenclamide is likely to be preferable to metformin and insulin in terms of acceptability and cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current Standard Care | Active comparator | Drug: InsulinInsulin + Metformin |
| Treatment | Active comparator | Drug: GlibenclamideGlibenclamide + Metformin |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Pregnant women diagnosed with gestational diabetes who fail to achieve "adequate glycaemic control" on maximum tolerated dose metformin
- Inadequate glycaemic control is defined according to the SIGN 116 guidelines.
Key exclusion criteria (6 listed)
- Pregnant women requiring insulin prior to 20 weeks gestation or after 36 weeks gestation.
- Pregnant women not taking at least 500mg metformin daily.
- Patients with suspected Type 1 diabetes mellitus presenting in pregnancy.
- Women with allergies to either glibenclamide or insulin or any of their excipients.
- Women with any contraindications to sulfonylurea therapy.
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 |
|---|---|---|
| Glibenclamide | Drug | Treatment |
| Insulin | Drug | Current Standard Care |
Primary outcome
Number of women willing to be randomised
Time frame: 2 years
* Retention - proportion of women randomised who remain in the study to provide outcomes * Adherence - proportion of clinicians who adhere to the treatment regimen(s)
6 secondary outcomes
Glycaemic control
Time frame: 2 weekly
Patient satisfaction
Time frame: 36-38 weeks gestation
Clinical outcomes
Time frame: 36 weeks
Clinical outcome
Time frame: 40 weeks
Clinical Outcome
Time frame: 40 weeks
Clinical Outcome
Time frame: 2 days
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 8 Dec 2016.
- Derived from this study: PubMed 28938877Reynolds RM, Denison FC, Juszczak E, Bell JL, Penneycard J, Strachan MWJ, Lindsay RS, Alexander CI, Love CDB, Whyte S, Mackenzie F, Stenson B, Norman JE. Glibenclamide and metfoRmin versus stAndard care in gEstational diabeteS (GRACES): a feasibility open label randomised trial. BMC Pregnancy Childbirth. 2017 Sep 22;17(1):316. doi: 10.1186/s12884-017-1505-3.
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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.
Jane E Norman, MD principal investigator
University of Edinburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glibenclamide and Insulin in people with Pregnancy and Gestational Diabetes, run by University of Edinburgh at 5 sites in United Kingdom.
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 2 inclusion and 6 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 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of women willing to be randomised (time frame: 2 years). 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 NCT02080377, which also lists 1 linked publication.
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 8 Dec 2016.