Diabetes Mellitus, Type 2Phase 4NCT04237493
Dosage Reduction and Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan
A Phase 4 study testing Metformin and Glimepiride (Low Dosage), Metformin and Vildagliptin (Low Dosage) and Metformin and Insulin Glargine U100 (Low Dosage) in people with Diabetes Mellitus, Type 2, run by University of Jordan at 1 site in Jordan.
Trial summary
Every lunar year, during the month of Ramadan, Muslims abstain from food and drink between dawn and nightfall. People with type 2 diabetes who fast during Ramadan are at an increased risk of acute glycemic complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin and Glimepiride (Low Dosage), Metformin and Vildagliptin (Low Dosage) and Metformin and Insulin Glargine U100 (Low Dosage)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 687 participants
- Where
- 1 siteJordan
- Study dates
- 14 Feb 2017to 24 Jul 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective participant is a returning patient with type 2 diabetes;
- Prospective participant expressed an intention to fast during Ramadan;
- Prospective participant has been compliant with one of four glucose-lowering multidrug regimens for at least the past three months.
Who cannot join
- Prospective participant is a pregnant, postpartum, breastfeeding, or eumenorrheic woman;
- Prospective participant has experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state within three months;
- Prospective participant has received niacin or corticosteroids within one month; and,
- Prospective participant has any history of recurrent hypoglycemia, hypoglycemia unawareness, chronic renal insufficiency (stages IV or V), liver cirrhosis, uncontrolled epilepsy, depressive disorder, bipolar disorder, psychotic disorder, or cognitive dysfunction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Dosage Reduction of Glucose-Lowering Multidrug Regimens on the Incidence of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: An Open-Label, Parallel-Group, Randomized, Controlled Trial
Every lunar year, during the month of Ramadan, Muslims abstain from food and drink between dawn and nightfall. People with type 2 diabetes who fast during Ramadan are at an increased risk of acute glycemic complications. Our aim is to investigate the effect of dosage reduction of four glucose-lowering multidrug regimens on the incidence of acute glycemic complications in people with type 2 diabetes who fast during Ramadan.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Metformin and Glimepiride (Low Dosage), Metformin and Vildagliptin (Low Dosage), Metformin and Insulin Glargine U100 (Low Dosage), Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage), Metformin and Glimepiride (Regular Dosage)
- Keywords
- Diabetes Mellitus, Type 2, Fasting, Hypoglycemic Agents, Hypoglycemia, Hyperglycemia, Diabetic Ketoacidosis, Hyperglycemic Hyperosmolar Nonketotic Coma, Metformin, Glimepiride, Vildagliptin, Insulin Glargine, Insulin, Regular, Human
- Medical subject headings
- Diabetes Mellitus, Type 2, Fasting, Hypoglycemia, Hyperglycemia, Diabetic Ketoacidosis, Hyperglycemic Hyperosmolar Nonketotic Coma, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin and Glimepiride (Low Dosage)Drug
- Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
- Glimepiride (PO; 1.5 or 3 mg [75% of the pre-Ramadan dose]; OD [with Ifṭār])
Metformin and Vildagliptin (Low Dosage)Drug
- Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
- Vildagliptin (PO; 50 mg; OD [with Ifṭār])
Metformin and Insulin Glargine U100 (Low Dosage)Drug
- Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
- Insulin Glargine U100 (SC; 9-33 units [75% of the pre-Ramadan dose]; OD [at 10 P.M.])
Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)Drug
- Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
- Insulin Glargine U100 (SC; 6-39 units (75% of the pre-Ramadan dose); OD [at 10 P.M.])
- Human Regular Insulin (SC; 15-33 units before Ifṭār and 6-18 units before Suḥūr [75% of the pre-Ramadan doses])
Metformin and Glimepiride (Regular Dosage)Drug
- Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
- Glimepiride (PO; 2 or 4 mg [100% of the pre-Ramadan dose]; OD [with Ifṭār])
Metformin and Vildagliptin (Regular Dosage)Drug
- Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
- Vildagliptin (PO; 50 mg; BID [with Ifṭār and with Suḥūr]])
Metformin and Insulin Glargine U100 (Regular Dosage)Drug
- Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
- Insulin Glargine U100 (SC; 11-44 units [100% of the pre-Ramadan dose]; OD [at 10 P.M.])
Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)Drug
- Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
- Insulin Glargine U100 (SC; 8-52 units (100% of the pre-Ramadan dose); OD [at 10 P.M.])
- Human Regular Insulin (SC; 12-40 units before Ifṭār and 7-28 units before Suḥūr [100% of the pre-Ramadan doses])
| Study group | Role | What they receive |
|---|---|---|
| Low-dosage therapy | Experimental | Not described Receives: Drug: Metformin and Glimepiride (Low Dosage); Drug: Metformin and Vildagliptin (Low Dosage); Drug: Metformin and Insulin Glargine U100 (Low Dosage); Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage) |
| Regular-dosage therapy | Active comparator | Not described Receives: Drug: Metformin and Glimepiride (Regular Dosage); Drug: Metformin and Vildagliptin (Regular Dosage); Drug: Metformin and Insulin Glargine U100 (Regular Dosage); Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia
Incidence of hypoglycemia
Measured: 29 days of Ramadan
Hyperglycemia
Incidence of hyperglycemia
Measured: 29 days of Ramadan
Secondary outcomes (2)
Diabetic ketoacidosis
Incidence of diabetic ketoacidosis
Measured: 29 days of Ramadan
Hyperosmolar hyperglycemic state
Incidence of hyperosmolar hyperglycemic state
Measured: 29 days of Ramadan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start14 Feb 2017
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
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 Diabetes Mellitus, Type 2Studies 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
- None (open label)
- Enrolment
- 687 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman A. Zayed, MD, University of Jordan
- Investigators
- Ayman A. Zayed, MD, Principal investigator, The University of Jordan School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237493
- Sponsor's protocol ID
- 671201612222
- Status last verified
- Feb 2020
- First submitted
- 17 Jan 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zaghlol LY, Beirat AF, Amarin JZ, Hassoun Al Najar AM, Hasan YY, Qtaishat A, Tierney ME, Zaghlol RY, Zayed AA. Effect of Dosage Reduction of Hypoglycemic Multidrug Regimens on the Incidences of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: A Randomized Controlled Trial. Front Endocrinol (Lausanne). 2021 Jul 7;12:613826. doi: 10.3389/fendo.2021.613826. eCollection 2021.
PubMed 34305809
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dosage Reduction of Glucose-Lowering Multidrug Regimens on the Incidence of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: An Open-Label, Parallel-Group, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04237493
- Acronym / sponsor ID
- 671201612222
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Fasting, Hypoglycemic Agents, Hypoglycemia, Hyperglycemia, Diabetic Ketoacidosis, Hyperglycemic Hyperosmolar Nonketotic Coma, Metformin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 687 participants (actual)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 23 Jan 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.
Every lunar year, during the month of Ramadan, Muslims abstain from food and drink between dawn and nightfall. People with type 2 diabetes who fast during Ramadan are at an increased risk of acute glycemic complications. Our aim is to investigate the effect of dosage reduction of four glucose-lowering multidrug regimens on the incidence of acute glycemic complications in people with type 2 diabetes who fast during Ramadan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-dosage therapy | Experimental | Drug: Metformin and Glimepiride (Low Dosage), Drug: Metformin and Vildagliptin (Low Dosage), Drug: Metformin and Insulin Glargine U100 (Low Dosage), Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage) |
| Regular-dosage therapy | Active comparator | Drug: Metformin and Glimepiride (Regular Dosage), Drug: Metformin and Vildagliptin (Regular Dosage), Drug: Metformin and Insulin Glargine U100 (Regular Dosage), Drug: Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Prospective participant is a returning patient with type 2 diabetes;
- Prospective participant expressed an intention to fast during Ramadan;
- Prospective participant has been compliant with one of four glucose-lowering multidrug regimens for at least the past three months.
Key exclusion criteria (4 listed)
- Prospective participant is a pregnant, postpartum, breastfeeding, or eumenorrheic woman;
- Prospective participant has experienced diabetic ketoacidosis or hyperosmolar hyperglycemic state within three months;
- Prospective participant has received niacin or corticosteroids within one month; and,
- Prospective participant has any history of recurrent hypoglycemia, hypoglycemia unawareness, chronic renal insufficiency (stages IV or V), liver cirrhosis, uncontrolled epilepsy, depressive disorder, bipolar disorder, psychotic disorder, or cognitive dysfunction.
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 |
|---|---|---|
| Metformin and Glimepiride (Low Dosage)* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) * Glimepiride (PO; 1.5 or 3 mg [75% of the pre-Ramadan dose]; OD [with Ifṭār]) | Drug | Low-dosage therapy |
| Metformin and Vildagliptin (Low Dosage)* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) * Vildagliptin (PO; 50 mg; OD [with Ifṭār]) | Drug | Low-dosage therapy |
| Metformin and Insulin Glargine U100 (Low Dosage)* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) * Insulin Glargine U100 (SC; 9-33 units [75% of the pre-Ramadan dose]; OD [at 10 P.M.]) | Drug | Low-dosage therapy |
| Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) * Insulin Glargine U100 (SC; 6-39 units (75% of the pre-Ramadan dose); OD [at 10 P.M.]) * Human Regular Insulin (SC; 15-33 units before Ifṭār and 6-18 units before Suḥūr [75% of the pre-Ramadan doses]) | Drug | Low-dosage therapy |
| Metformin and Glimepiride (Regular Dosage)* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) * Glimepiride (PO; 2 or 4 mg [100% of the pre-Ramadan dose]; OD [with Ifṭār]) | Drug | Regular-dosage therapy |
| Metformin and Vildagliptin (Regular Dosage)* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) * Vildagliptin (PO; 50 mg; BID [with Ifṭār and with Suḥūr]]) | Drug | Regular-dosage therapy |
| Metformin and Insulin Glargine U100 (Regular Dosage)* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) * Insulin Glargine U100 (SC; 11-44 units [100% of the pre-Ramadan dose]; OD [at 10 P.M.]) | Drug | Regular-dosage therapy |
| Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)* Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr]) * Insulin Glargine U100 (SC; 8-52 units (100% of the pre-Ramadan dose); OD [at 10 P.M.]) * Human Regular Insulin (SC; 12-40 units before Ifṭār and 7-28 units before Suḥūr [100% of the pre-Ramadan doses]) | Drug | Regular-dosage therapy |
Primary outcome
Hypoglycemia
Time frame: 29 days of Ramadan
Incidence of hypoglycemia
Hyperglycemia
Time frame: 29 days of Ramadan
Incidence of hyperglycemia
2 secondary outcomes
Diabetic ketoacidosis
Time frame: 29 days of Ramadan
Hyperosmolar hyperglycemic state
Time frame: 29 days of Ramadan
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 11 Feb 2020.
- Derived from this study: PubMed 34305809Zaghlol LY, Beirat AF, Amarin JZ, Hassoun Al Najar AM, Hasan YY, Qtaishat A, Tierney ME, Zaghlol RY, Zayed AA. Effect of Dosage Reduction of Hypoglycemic Multidrug Regimens on the Incidences of Acute Glycemic Complications in People With Type 2 Diabetes Who Fast During Ramadan: A Randomized Controlled Trial. Front Endocrinol (Lausanne). 2021 Jul 7;12:613826. doi: 10.3389/fendo.2021.613826. eCollection 2021.
- Individual participant dataSharing planned: Yes
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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.
Ayman A. Zayed, MD principal investigator
The University of Jordan School of Medicine
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 Glimepiride (Low Dosage), Metformin and Vildagliptin (Low Dosage) and Metformin and Insulin Glargine U100 (Low Dosage) in people with Diabetes Mellitus, Type 2, run by University of Jordan at 1 site in Jordan.
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 3 inclusion and 4 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 11 Feb 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 Jordan. 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?
Hypoglycemia (time frame: 29 days of Ramadan). The study lists 2 primary outcomes in all. 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 NCT04237493, 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 11 Feb 2020.