Type1 Diabetes MellitusPhase 4NCT03928340
Effect of Adding Metformin to Insulin Therapy on Pregnancy Outcomes in Women With Uncontrolled Type I Diabetes.
A Phase 4 study testing Metformin and Insulin in people with Type1 Diabetes Mellitus, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Type1 Diabetes Mellitus
- What is being tested?
- Metformin and Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Apr 2019to 29 Mar 2020
- Phase
- Phase 4
- 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
- Diabetic pregnant patients with type one diabetes and no other chronic disorders
- Patients on insulin in the 3rd trimester of pregnancy (on insulin therapy since start of gestation)
- Patients pregnant in single living fetus with no apparent congenital anomalies
- Haemoglobin A 1 C (HbA1c) level between 7% to 11%
- All patients have done a dating ultrasound to confirm gestational age, viability and rule out any abnormality
Who cannot join
- Patients with type 2 or gestational diabetes
- Patients with intolerance or hypersensitivity to metformin
- Patients with congestive heart failure or a history of congestive heart failure
- Patients with renal insufficiency
- Patients having current significant gastrointestinal problems such as severe vomiting requiring intravenous fluids or hospitalization
- Presence of acute or chronic metabolic acidosis, including diabetic ketoacidosis, a history of diabetic ketoacidosis or history of lactic acidosis
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- Patients with liver impairment
- Patients with known higher order pregnancies (twins, triplets, etc.)
- Patients having a known potentially fetal lethal anomaly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adding Metformin to Insulin Therapy in Pregnant Women With Type I Diabetes as Regards Pregnancy Outcome
A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone. Group assignment will be randomized by computer program.
Read the detailed description
A total of 80 uncontrolled diabetic pregnant patients in the 3rd trimester seeking medical advice in Beni-Suef University Hospital and meet the eligibility criteria, are approached about participation in the trial and given information pamphlets describing the study. The patients are asked to sign a consent form and will be assigned to one of the 2 groups: Group A (study group); will include 40 patients who will be treated with metformin
(1 gm twice daily (with the 2 main meals)), combined with insulin therapy Group B (control group); will include 40 patients who will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations) All patients will be managed according to NICE guidelines for diabetes with pregnancy (2015) Maternal assessment
- Full history taking Baseline medical history is obtained along with other baseline demographics and concomitant medications including insulin regimen and dose.
- Thorough clinical examination Maternal weight, height and blood pressure measured and recorded.
- Laboratory investigations;
- Routine labs: CBC, coagulation profile, liver and kidney function at time of participation, 28-32 weeks of gestation especially renal parameter serum Creatinine.
- HbA1c at time of 1st examination.
- FBS, 2h post prandial blood sugar will be done weekly from time of participation till time of delivery
- Fundus examination for early detection of retinal affection at Ophthalmology clinic
Follow up:
- Fetal weight gain weekly
- Maternal weight gain weekly
Accordingly:
- Uncontrolled cases will follow up weekly in the High Risk Pregnancy outpatient clinic until 36 weeks and then admitted to High risk pregnancy department for termination of pregnancy
- Fetal surveillance will be done by ;CTG weekly, Ultrasound weekly and Fetal kick count daily
- Resistant uncontrolled cases will be admitted to high risk pregnancy department where capillary blood sugar will be measured 7 times daily Fetal surveillance will be done by ; CTG Daily, Ultrasound every 3 days and Fetal kick count daily
Assessment of Patients at time of termination by:
- Fasting blood sugar , 2 hours post prandial blood sugar and HBA1C
- Routine preoperative labs. CBC, coagulation profile, liver and kidney function
- Fetal weight
- Maternal weight Neonatal assessment after delivery include the following; APGAR score, neonatal weight, incidence of transient tachypnea of newborn (TTN), acute respiratory distress syndrome (ARDS), neonatal hypoglycemia and NICU admission.
- Conditions
- Type1 Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
40 patients will be treated with metformin
(1 gm twice daily (with the 2 main meals)), combined with insulin therapy
InsulinDrug
40 patients will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations)
| Study group | Role | What they receive |
|---|---|---|
| combined metformin and insulin | Active comparator | Not described Receives: Drug: Metformin; Drug: Insulin |
| Insulin only | Other | Not described Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
the change in level of glycosylated haemoglobin
Measured: 12 weeks
capillary glucose
the change in level of glucose in capillary blood
Measured: 12 weeks
fasting blood sugar measurement.
the change in level of glucose in venous blood after fasting for 8 hours
Measured: 12 weeks
2 hours post prandial blood sugar measurement.
the change in level of glucose in venous blood 2 hours after meal
Measured: 12 weeks
Secondary outcomes (10)
Maternal weight gain
the change in mothers' weight in kilograms
Measured: 12 weeks
weekly fetal weight gain measured by ultrasound
the change of fetal weight measured by ultrasound
Measured: 12 weeks
insulin requirements
the change in dose of insulin taken by patient
Measured: 12 weeks
attacks of maternal hypoglycemia
Number of patients with plasma glucose level below 65 mg/dl
Measured: 12 weeks
intra uterine fetal death (IUFD)
The number of patients with death of fetus after 20 weeks of gestation
Measured: 12 weeks
neonatal weight
The change in neonatal weight in kilograms
Measured: 12 weeks
preterm birth
The number of patients giving birth berfore 37 completed weeks
Measured: 12 weeks
neonatal respiratory distress
the number of neonates with neonatal respiratory distress
Measured: 12 weeks
neonatal hypoglycemia
the number of neonates with plasma glucose level below less than 45 mg/dL (2.5 mmol/L)
Measured: 12 weeks
neonatal Intensive care admission
the number of neonates with neonatal Intensive care admission
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start29 Apr 2019
- Primary completion29 Mar 2020
- Study completion29 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Amal Kotb Abdallah, Amir Gabr, Mohamed Abdeltawwab Mahmoud
- Responsible party
- Principal investigator, Amira S Dieb, Kasr El Aini Hospital
- Investigators
- Amal kotb, Principal investigator, Beniswef university hospitalAmir Gabr, Principal investigator, Cairo university kasrelainy hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928340
- Sponsor's protocol ID
- FMBSUREC/05032019/Abd Alaziz
- Status last verified
- May 2020
- First submitted
- 20 Apr 2019
- Last updated
- 28 May 2020
- 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 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Metformin to Insulin Therapy in Pregnant Women With Type I Diabetes as Regards Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT03928340
- Acronym / sponsor ID
- FMBSUREC/05032019/Abd Alaziz
- Conditions
- Type1 Diabetes Mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Collaborators
- Amal Kotb Abdallah, Amir Gabr, Mohamed Abdeltawwab Mahmoud
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- 29 Mar 2020 (actual)
- Study completion
- 29 Mar 2020 (actual)
- First posted
- 26 Apr 2019 (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.
A randomized controlled clinical trial will be conducted in KasrELAiny hospitals, Cairo University and Beni-Suef University Hospital, including 80 uncontrolled diabetic pregnant women (type I) in the 3rd trimester (28-32 weeks of pregnancy) divided equally into study group and control group, to compare the usage of both metformin and insulin instead of using insulin alone. Group assignment will be randomized by computer program.
Detailed description
A total of 80 uncontrolled diabetic pregnant patients in the 3rd trimester seeking medical advice in Beni-Suef University Hospital and meet the eligibility criteria, are approached about participation in the trial and given information pamphlets describing the study. The patients are asked to sign a consent form and will be assigned to one of the 2 groups: Group A (study group); will include 40 patients who will be treated with metformin
(1 gm twice daily (with the 2 main meals)), combined with insulin therapy Group B (control group); will include 40 patients who will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations) All patients will be managed according to NICE guidelines for diabetes with pregnancy (2015) Maternal assessment
- Full history taking Baseline medical history is obtained along with other baseline demographics and concomitant medications including insulin regimen and dose.
- Thorough clinical examination Maternal weight, height and blood pressure measured and recorded.
- Laboratory investigations;
- Routine labs: CBC, coagulation profile, liver and kidney function at time of participation, 28-32 weeks of gestation especially renal parameter serum Creatinine.
- HbA1c at time of 1st examination.
- FBS, 2h post prandial blood sugar will be done weekly from time of participation till time of delivery
- Fundus examination for early detection of retinal affection at Ophthalmology clinic
Follow up:
- Fetal weight gain weekly
- Maternal weight gain weekly
Accordingly:
- Uncontrolled cases will follow up weekly in the High Risk Pregnancy outpatient clinic until 36 weeks and then admitted to High risk pregnancy department for termination of pregnancy
- Fetal surveillance will be done by ;CTG weekly, Ultrasound weekly and Fetal kick count daily
- Resistant uncontrolled cases will be admitted to high risk pregnancy department where capillary blood sugar will be measured 7 times daily Fetal surveillance will be done by ; CTG Daily, Ultrasound every 3 days and Fetal kick count daily
Assessment of Patients at time of termination by:
- Fasting blood sugar , 2 hours post prandial blood sugar and HBA1C
- Routine preoperative labs. CBC, coagulation profile, liver and kidney function
- Fetal weight
- Maternal weight Neonatal assessment after delivery include the following; APGAR score, neonatal weight, incidence of transient tachypnea of newborn (TTN), acute respiratory distress syndrome (ARDS), neonatal hypoglycemia and NICU admission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined metformin and insulin | Active comparator | Drug: Metformin, Drug: Insulin |
| Insulin only | Other | Drug: Insulin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diabetic pregnant patients with type one diabetes and no other chronic disorders
- Patients on insulin in the 3rd trimester of pregnancy (on insulin therapy since start of gestation)
- Patients pregnant in single living fetus with no apparent congenital anomalies
- Haemoglobin A 1 C (HbA1c) level between 7% to 11%
- All patients have done a dating ultrasound to confirm gestational age, viability and rule out any abnormality
Key exclusion criteria (9 listed)
- Patients with type 2 or gestational diabetes
- Patients with intolerance or hypersensitivity to metformin
- Patients with congestive heart failure or a history of congestive heart failure
- Patients with renal insufficiency
- Patients having current significant gastrointestinal problems such as severe vomiting requiring intravenous fluids or hospitalization
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 |
|---|---|---|
| Metformin40 patients will be treated with metformin (1 gm twice daily (with the 2 main meals)), combined with insulin therapy | Drug | combined metformin and insulin |
| Insulin40 patients will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations) | Drug | Insulin only, combined metformin and insulin |
Primary outcome
HbA1c
Time frame: 12 weeks
the change in level of glycosylated haemoglobin
capillary glucose
Time frame: 12 weeks
the change in level of glucose in capillary blood
fasting blood sugar measurement.
Time frame: 12 weeks
the change in level of glucose in venous blood after fasting for 8 hours
2 hours post prandial blood sugar measurement.
Time frame: 12 weeks
the change in level of glucose in venous blood 2 hours after meal
10 secondary outcomes
Maternal weight gain
Time frame: 12 weeks
weekly fetal weight gain measured by ultrasound
Time frame: 12 weeks
insulin requirements
Time frame: 12 weeks
attacks of maternal hypoglycemia
Time frame: 12 weeks
intra uterine fetal death (IUFD)
Time frame: 12 weeks
neonatal weight
Time frame: 12 weeks
preterm birth
Time frame: 12 weeks
neonatal respiratory distress
Time frame: 12 weeks
neonatal hypoglycemia
Time frame: 12 weeks
neonatal Intensive care admission
Time frame: 12 weeks
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 28 May 2020.
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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.
Amal kotb principal investigator
Beniswef university hospital
Amir Gabr principal investigator
Cairo university kasrelainy hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Insulin in people with Type1 Diabetes Mellitus, run by Kasr El Aini Hospital 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 5 inclusion and 9 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 28 May 2020. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
HbA1c (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 28 May 2020.