Diabetes, Type 2NCT01624116
Comparison of Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetes
A study testing Acarbose, Diet and lifestyle and Metformin in people with Diabetes, Type 2, run by Services Hospital, Lahore at 1 site in Pakistan.
Trial summary
Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Type 2
- What is being tested?
- Acarbose, Diet and lifestyle and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2011to Sep 2011
- 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
- HbA1c 6.5-9.5%.
- Type 2 diabetics on two or less oral hypoglycaemic agents.
Who cannot join
- Any contraindications either to fasting or to any of the trial medication.
- Pregnancy.
- Serum creatinine > 1.4 mg/dl.
- Serum ALT > twice upper limit normal.
- History of pancreatitis, serum amylase > twice upper limit normal.
- History of intolerance to acarbose.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Endocrinology Unit & Diabetes Management Centre, Services Hospital.
Lahore
About this study
Official title: A Comparison of Four Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetic Patients and the Effect of Add-On Acarbose on Glycaemic Excursions During Ramadan Fasting
Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these excursions and reduce risks of fast to a minimum.
Read the detailed description
Study Objectives:
- To compare changes in clinical and metabolic parameters from baseline to the end of four weeks fasting in Ramadan between four treatment arms:
- diet and lifestyle measures alone.
- metformin monotherapy.
- combination therapy with metformin + sulfonylurea.
- combination therapy with metformin + sitagliptin.
- To compare the 24 hour CGMS profile during Ramadan fasting in type 2 diabetic patients before and after addition of acarbose to these pre-existing sub-maximal hypoglycaemic regimens.
- Conditions
- Diabetes, Type 2
- Being tested
- Acarbose, Diet and lifestyle, Metformin, Metformin/ Glimepride, Metformin/Sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
Also called *Tab.Glucobay 50mg (Bayer).
Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
Diet and lifestyleOther
Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
MetforminDrug
Also called Tablets Glucophage (Merck)
Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose
Metformin/ GlimeprideDrug
Also called Tablet Getformin 1/500 (Getz Pharma)
Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
Metformin/SitagliptinDrug
Also called Tab.TreviaMet 50/500 (Getz Pharma)
Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.
| Study group | Role | What they receive |
|---|---|---|
| Diet and lifestyle measures alone. | Active comparator | Type 2 diabetic subjects on lifestyle counselling as part of diabetes treatment would continue as such during Ramadan. They would receive acarbose on one day to be followed by CGMS for a 24 hour period Receives: Drug: Acarbose; Other: Diet and lifestyle |
| Metformin monotherapy | Active comparator | Type 2 diabetics on biguanide treatment. Receives: Drug: Acarbose; Other: Diet and lifestyle; Drug: Metformin |
| Metformin + Sulphonylurea. | Active comparator | Type 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride. Receives: Drug: Acarbose; Other: Diet and lifestyle; Drug: Metformin/ Glimepride |
| Metformin + Sitagliptin | Active comparator | Type 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin. Receives: Drug: Acarbose; Other: Diet and lifestyle; Drug: Metformin/Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight and fructosamine levels during Ramadan fasting.
Change in body weight and fructosamine levels from baseline to end of Ramadan.
Measured: 28 days (Average duration of Ramadan fasting)
Secondary outcomes (3)
Change in fasting lipid profile from baseline to end of Ramadan.
Change in fasting lipid profile from baseline to end of Ramadan.
Measured: 28 days(average duration of Ramadan)
Change in ghrelin levels from baseline to end of Ramadan.
Change in ghrelin levels from baseline to end of Ramadan.
Measured: 28days (average duration of Ramadan)
Change in renal profile from baseline to end of Ramadan
Change in renal profile from baseline to end of Ramadan.
Measured: 28 days(average duration of Ramadan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Services Hospital, Lahore
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Saira Burney, Services Hospital, Lahore
- Investigators
- Dr Khadija Irfan, MBBS,FCPS, Principal investigator, Services Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01624116
- Sponsor's protocol ID
- RT2011
- Status last verified
- Jun 2012
- First submitted
- 19 Mar 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Four Hypoglycaemic Regimens During Ramadan Fasting in Type 2 Diabetic Patients and the Effect of Add-On Acarbose on Glycaemic Excursions During Ramadan Fasting
- ClinicalTrials.gov ID
- NCT01624116
- Acronym / sponsor ID
- RT2011
- Conditions
- Diabetes, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Services Hospital, LahoreOther government
- Study start
- Aug 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Jun 2012 (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.
Type 2 diabetic patients who fast during Ramadan experience swings in glycaemic control between hypoglycaemic troughs and hyperglycaemic spikes. Hence, the dual challenge in fasting diabetics is to identify which treatment modality leads to the most stable blood glucose levels during a fast and how to smooth out these excursions and reduce risks of fast to a minimum.
Detailed description
Study Objectives:
- To compare changes in clinical and metabolic parameters from baseline to the end of four weeks fasting in Ramadan between four treatment arms:
- diet and lifestyle measures alone.
- metformin monotherapy.
- combination therapy with metformin + sulfonylurea.
- combination therapy with metformin + sitagliptin.
- To compare the 24 hour CGMS profile during Ramadan fasting in type 2 diabetic patients before and after addition of acarbose to these pre-existing sub-maximal hypoglycaemic regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diet and lifestyle measures alone. | Active comparator | Drug: Acarbose, Other: Diet and lifestyleType 2 diabetic subjects on lifestyle counselling as part of diabetes treatment would continue as such during Ramadan. They would receive acarbose on one day to be followed by CGMS for a 24 hour period |
| Metformin monotherapy | Active comparator | Drug: Acarbose, Other: Diet and lifestyle, Drug: MetforminType 2 diabetics on biguanide treatment. |
| Metformin + Sulphonylurea. | Active comparator | Drug: Acarbose, Other: Diet and lifestyle, Drug: Metformin/ GlimeprideType 2 diabetics on dual oral hypoglycaemics-metformin and glimepiride. |
| Metformin + Sitagliptin | Active comparator | Drug: Acarbose, Other: Diet and lifestyle, Drug: Metformin/SitagliptinType 2 diabetics managed on dual oral hypoglycaemic therapies: metformin and sitagliptin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- HbA1c 6.5-9.5%.
- Type 2 diabetics on two or less oral hypoglycaemic agents.
Key exclusion criteria (6 listed)
- Any contraindications either to fasting or to any of the trial medication.
- Pregnancy.
- Serum creatinine > 1.4 mg/dl.
- Serum ALT > twice upper limit normal.
- History of pancreatitis, serum amylase > twice upper limit normal.
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 |
|---|---|---|
| AcarboseAlso: *Tab.Glucobay 50mg (Bayer).Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm. | Drug | Diet and lifestyle measures alone., Metformin + Sitagliptin, Metformin + Sulphonylurea., Metformin monotherapy |
| Diet and lifestylePatients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day | Other | Diet and lifestyle measures alone., Metformin + Sitagliptin, Metformin + Sulphonylurea., Metformin monotherapy |
| MetforminAlso: Tablets Glucophage (Merck)Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose | Drug | Metformin monotherapy |
| Metformin/ GlimeprideAlso: Tablet Getformin 1/500 (Getz Pharma)Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD | Drug | Metformin + Sulphonylurea. |
| Metformin/SitagliptinAlso: Tab.TreviaMet 50/500 (Getz Pharma)Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD. | Drug | Metformin + Sitagliptin |
Primary outcome
Change in body weight and fructosamine levels during Ramadan fasting.
Time frame: 28 days (Average duration of Ramadan fasting)
Change in body weight and fructosamine levels from baseline to end of Ramadan.
3 secondary outcomes
Change in fasting lipid profile from baseline to end of Ramadan.
Time frame: 28 days(average duration of Ramadan)
Change in ghrelin levels from baseline to end of Ramadan.
Time frame: 28days (average duration of Ramadan)
Change in renal profile from baseline to end of Ramadan
Time frame: 28 days(average duration 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 20 Jun 2012.
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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.
Dr Khadija Irfan, MBBS,FCPS principal investigator
Services Hospital.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acarbose, Diet and lifestyle and Metformin in people with Diabetes, Type 2, run by Services Hospital, Lahore at 1 site in Pakistan.
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 20 Jun 2012. 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 Pakistan. 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.
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?
Change in body weight and fructosamine levels during Ramadan fasting. (time frame: 28 days (Average duration of Ramadan fasting)). 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 20 Jun 2012.