Long Acting Insulin in Control of Gestational Diabetes MellitusPhase 2/3NCT04674332
Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus
A Phase 2/3 study testing Long acting insulin and multiple dose regimen in people with Long Acting Insulin in Control of Gestational Diabetes Mellitus, run by Ain Shams University at 1 site in Egypt.
Trial summary
multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Long Acting Insulin in Control of Gestational Diabetes Mellitus
- What is being tested?
- Long acting insulin and multiple dose regimen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 14 Dec 2020
- Phase
- Phase 2/3
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women with gestational diabetes mellitus
- between 24-28 weeks gestation
Who cannot join
- other endocrinological abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Use of Long Acting Insulin Versus Multiple Dose Regimen in Control of Gestational Diabetes Mellitus
multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin
- Being tested
- Long acting insulin, multiple dose regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long acting insulinDrug
long acting insulin analogue once daily at bed time
multiple dose regimenDrug
intermediate and short acting insulin
| Study group | Role | What they receive |
|---|---|---|
| long acting insulin | Experimental | Not described Receives: Drug: Long acting insulin |
| multiple dose regimen | Active comparator | Not described Receives: Drug: multiple dose regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
time needed to achieve glycemic control
glycemic control assessed by fasting and postprandial blood sugar
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2020
- Study start1 Sep 2019
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Acting Insulin in Control of Gestational Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maii medhat nawara, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04674332
- Sponsor's protocol ID
- 323/2019
- Status last verified
- Sep 2021
- First submitted
- 14 Dec 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Use of Long Acting Insulin Versus Multiple Dose Regimen in Control of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04674332
- Acronym / sponsor ID
- 323/2019
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 19 Dec 2020 (actual)
- 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.
multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| long acting insulin | Experimental | Drug: Long acting insulin |
| multiple dose regimen | Active comparator | Drug: multiple dose regimen |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant women with gestational diabetes mellitus
- between 24-28 weeks gestation
Key exclusion criteria (1 listed)
- other endocrinological abnormalities
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 |
|---|---|---|
| Long acting insulinlong acting insulin analogue once daily at bed time | Drug | long acting insulin |
| multiple dose regimenintermediate and short acting insulin | Drug | multiple dose regimen |
Primary outcome
time needed to achieve glycemic control
Time frame: 1 year
glycemic control assessed by fasting and postprandial blood sugar
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 Sep 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Long acting insulin and multiple dose regimen in people with Long Acting Insulin in Control of Gestational Diabetes Mellitus, run by Ain Shams University at 1 site in Egypt.
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 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 8 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
time needed to achieve glycemic control (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2021.