Type 2 Diabetes MellitusPhase 4STEADFASTNCT01758380
Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
A Phase 4 study testing Vildagliptin, Gliclazide and Metformin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 68 sites in 16 countries.
Trial summary
To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Vildagliptin, Gliclazide and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 557 participants
- Where
- 68 sitesin 16 countries
- Study dates
- Jan 2013to Sep 2013
- 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
- Confirmed Type 2 Diabetes diagnosis
- Plan to fast during Ramadan
- Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1
- Taking a sulfonylurea treatment for less than 3 years prior to Visit 1
- Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1
Who cannot join
- Pregnant or nursing (lactating) women
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component.
- Inability to comply with the study procedures or medications.
- "Other protocol-defined inclusion/exclusion criteria may apply"
Trial locations and contacts
68 sites in 16 countries.
68 sites in 16 countries
Germany10 sites
Novartis Investigative Site
Augsburg, 86150
Novartis Investigative Site
Augsburg, 86159
Novartis Investigative Site
Bad Oeynhausen, 32549
Novartis Investigative Site
Berlin, 10997
Novartis Investigative Site
Dortmund, 44137
Novartis Investigative Site
Einbeck, 37574
Novartis Investigative Site
Löhne, 32584
Novartis Investigative Site
Meine, 38527
Novartis Investigative Site
München, 80339
Novartis Investigative Site
Saarlouis, 66740
Russia8 sites
Novartis Investigative Site
Krasnodar, 350063
Novartis Investigative Site
Penza, 440026
Novartis Investigative Site
Rostov-on-Don, 344000
Novartis Investigative Site
Rostov-on-Don, 344718
Novartis Investigative Site
Saint Petersburg, 191015
Novartis Investigative Site
Saint Petersburg, 199034
Novartis Investigative Site
Saratov, 410012
Novartis Investigative Site
Ufa, 450000
Spain8 sites
Novartis Investigative Site
Barcelona, Catalonia, 08001
Novartis Investigative Site
Ceuta, Ceuta, 51002
Novartis Investigative Site
Girona, Catalonia, 17007
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Melilla, Melilla, 52005
Novartis Investigative Site
Salt, Catalonia, 17190
Novartis Investigative Site
Santa Coloma de Gramanet, Catalonia, 08923
Novartis Investigative Site
Vic, Catalonia, 08500
United Kingdom8 sites
Novartis Investigative Site
Birmingham, B15 2TT
Novartis Investigative Site
Birmingham, B8 3Sw
Novartis Investigative Site
Birmingham, B9 5SS
Novartis Investigative Site
Bolton, BL4 0JR
Novartis Investigative Site
Derby, DE22 3NE
Novartis Investigative Site
Leicester, Leicestershire, LE5 4PW
Novartis Investigative Site
London, London, W6 7HY
Novartis Investigative Site
Manchester, M13 9WL
Tunisia7 sites
Novartis Investigative Site
Le Belvedere - Tunis, Tunisie, 1002
Novartis Investigative Site
Monastir, Tunisia, 5000
Novartis Investigative Site
Sfax, Tunisie, 3029
Novartis Investigative Site
Sousse, 4000
Novartis Investigative Site
Tunis, Tunisie, 1007
Novartis Investigative Site
Tunis, 1007
Novartis Investigative Site
Tunis
Indonesia5 sites
Novartis Investigative Site
Jakarta, Jakarta Special Capital Region, 10220
Novartis Investigative Site
Jakarta, Jakarta Special Capital Region, 10430
Novartis Investigative Site
Malang, East Java, 65111
Novartis Investigative Site
Padang, West Sumatra, 25127
Novartis Investigative Site
Surabaya, East Java, 60286
Turkey (Türkiye)5 sites
Novartis Investigative Site
Diskapi / Ankara, Turkey, 06770
Novartis Investigative Site
Istanbul, Turkey, 34304
Novartis Investigative Site
Istanbul, 34093
Novartis Investigative Site
Izmir, 35380
Novartis Investigative Site
Kahramanmaraş, 46050
Lebanon4 sites
Novartis Investigative Site
Beirut, 1107 2020
Novartis Investigative Site
Beirut
Novartis Investigative Site
Hazmiyeh, 470
Novartis Investigative Site
Saida
Singapore3 sites
Novartis Investigative Site
Singapore, Singapore, 440080
Novartis Investigative Site
Singapore, Singapore, 545025
Novartis Investigative Site
Singapore, Singapore, 659164
Egypt2 sites
Novartis Investigative Site
Alexandria, 21131
Novartis Investigative Site
Cairo, 11566
Malaysia2 sites
Novartis Investigative Site
Kota Bharu, Kelantan, 16150
Novartis Investigative Site
Kuala Lumpur, 59100
Saudi Arabia2 sites
Novartis Investigative Site
Dammam, Dammam, 40145
Novartis Investigative Site
Riyadh, 11426
About this study
Official title: A Double Blind, Double Dummy, Randomised, Multi-centre Study to Assess the Tolerability and Efficacy Profile of Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Vildagliptin, Gliclazide, Metformin, Placebo to Gliclazide, Placebo to Vildagliptin
- Keywords
- Type 2 Diabetes Mellitus, Ramadan, Vildagliptin, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VildagliptinDrug
Also called Galvus
Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
GliclazideDrug
Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
MetforminDrug
Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
Placebo to GliclazideDrug
Patients will be instructed to take the Gliclazide matching placebo capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
Placebo to VildagliptinDrug
Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy).
| Study group | Role | What they receive |
|---|---|---|
| Vildagliptin + placebo to Gliclazide | Experimental | Vildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily. Receives: Drug: Vildagliptin; Drug: Metformin; Drug: Placebo to Gliclazide |
| Gliclazide + placebo to Vildagliptin | Active comparator | Gliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily. Receives: Drug: Gliclazide; Drug: Metformin; Drug: Placebo to Vildagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority
Measured: 1 month
Secondary outcomes (10)
Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs)
Measured: visit 3 (anytime from week -4 to day -1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) for HbA1c; and during 1 month (Ramadan) for HEs
Change from baseline to endpoint in glycosylated hemoglobin (HbA1c)
Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication
Measured: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)
Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c)
Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication
Measured: visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period
Measured: 1 month
mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day
assessed in a selected subgroup of patients
Measured: 72 hours
Treatment adherence during the Ramadan fasting period
Measured: 1 month
Change from visit 3 (pre-Ramadan visit) to endpoint in body weight
Endpoint is defined as the visit 4 (post-Ramadan) measurement or the last observation obtained during or after Ramadan, prior to or at initiation of rescue medication
Measured: From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Number of unscheduled visit to health care professional
Measured: From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Number of days fasted during the Ramadan fasting period
Measured: 1 month
Number of patients with treatment emergent adverse events (AEs), serious AEs, discontinuation due to AEs, deaths or laboratory abnormalities as assessment of safety and tolerability
Measured: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharma AG, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758380
- Sponsor's protocol ID
- CLAF237A2411
- Other IDs
- 2011-005499-41
- Acronym
- STEADFAST
- Status last verified
- Oct 2013
- First submitted
- 24 Dec 2012
- Last updated
- 17 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
PubMed 37435938Hassanein M, Abdallah K, Schweizer A. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study. Vasc Health Risk Manag. 2014 May 28;10:319-26. doi: 10.2147/VHRM.S64038. eCollection 2014.
PubMed 24920915
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Double Dummy, Randomised, Multi-centre Study to Assess the Tolerability and Efficacy Profile of Vildagliptin Compared to Gliclazide as Dual Therapy With Metformin in Muslim Patients With Type 2 Diabetes Fasting During Ramadan
- ClinicalTrials.gov ID
- NCT01758380
- Acronym / sponsor ID
- STEADFAST / CLAF237A2411
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 Diabetes Mellitus, Ramadan, Vildagliptin, Hypoglycemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 557 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Jan 2013 (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.
To evaluate vildagliptin as compared to gliclazide, given in combination with metformin in Muslim patients with type 2 diabetes fasting during Ramadan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vildagliptin + placebo to Gliclazide | Experimental | Drug: Vildagliptin, Drug: Metformin, Drug: Placebo to GliclazideVildagliptin tablets will be given at 50mg twice daily (bid). Placebo to Gliclazide capsules will be given at an equivalent dose to previous sulfonylurea in multiples of 80mg only (80-320 mg/day). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily. |
| Gliclazide + placebo to Vildagliptin | Active comparator | Drug: Gliclazide, Drug: Metformin, Drug: Placebo to VildagliptinGliclazide capsules will be given in multiples of 80 mg (80-320 mg/day) at a dose equivalent to previous sulfonylurea dose, unless at the investigator's discretion it could be up-titrated to the next available dose (if HbA1c is higher than 7.5%). Placebo to Vildagliptin tablets will be given at 50mg twice daily (bid). Patients will continue their open-label metformin therapy at dosage between 1500-2500 mg daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed Type 2 Diabetes diagnosis
- Plan to fast during Ramadan
- Treated with a combination of metformin and an Sulfonylurea (SU) for at least 12 weeks and HbA1c ≤8.5% at Visit 1
- Taking a sulfonylurea treatment for less than 3 years prior to Visit 1
- Body mass index (BMI) ≥22 and ≤45 kg/m2 at Visit 1
Key exclusion criteria (5 listed)
- Pregnant or nursing (lactating) women
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
- Patients who are taking any other anti-diabetes drug (oral or injection) other than metformin and an SU component.
- Inability to comply with the study procedures or medications.
- "Other protocol-defined inclusion/exclusion criteria may apply"
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 |
|---|---|---|
| VildagliptinAlso: GalvusPatients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy) | Drug | Vildagliptin + placebo to Gliclazide |
| GliclazidePatients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy) | Drug | Gliclazide + placebo to Vildagliptin |
| MetforminPatients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion | Drug | Gliclazide + placebo to Vildagliptin, Vildagliptin + placebo to Gliclazide |
| Placebo to GliclazidePatients will be instructed to take the Gliclazide matching placebo capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy) | Drug | Vildagliptin + placebo to Gliclazide |
| Placebo to VildagliptinPatients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy). | Drug | Gliclazide + placebo to Vildagliptin |
Primary outcome
Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority
Time frame: 1 month
10 secondary outcomes
Percentage of patients without an increase in HbA1c (≤ 0.3%) and with no Hypoglycaemic Events (HEs)
Time frame: visit 3 (anytime from week -4 to day -1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks) for HbA1c; and during 1 month (Ramadan) for HEs
Change from baseline to endpoint in glycosylated hemoglobin (HbA1c)
Time frame: baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 weeks)
Change from visit 3 (pre-Ramadan visit) to endpoint in glycosylated hemoglobin (HbA1c)
Time frame: visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Proportion of patients experiencing severe hypoglycemic events during the Ramadan fasting period
Time frame: 1 month
mean amplitude of glycemic excursions (MAGE) to measure glucose fluctuations during the day
Time frame: 72 hours
Treatment adherence during the Ramadan fasting period
Time frame: 1 month
Change from visit 3 (pre-Ramadan visit) to endpoint in body weight
Time frame: From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Number of unscheduled visit to health care professional
Time frame: From visit 3 (anytime from week-4 to day-1 before start of Ramadan) to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 4.5 weeks to maximum 12 weeks)
Number of days fasted during the Ramadan fasting period
Time frame: 1 month
Number of patients with treatment emergent adverse events (AEs), serious AEs, discontinuation due to AEs, deaths or laboratory abnormalities as assessment of safety and tolerability
Time frame: Baseline to visit 4 (within 4 weeks post-Ramadan fasting period) (minimum 12.5 weeks to maximum 30 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 17 Oct 2013.
- Derived from this study: PubMed 37435938Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.
- Derived from this study: PubMed 24920915Hassanein M, Abdallah K, Schweizer A. A double-blind, randomized trial, including frequent patient-physician contacts and Ramadan-focused advice, assessing vildagliptin and gliclazide in patients with type 2 diabetes fasting during Ramadan: the STEADFAST study. Vasc Health Risk Manag. 2014 May 28;10:319-26. doi: 10.2147/VHRM.S64038. eCollection 2014.
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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.
Novartis Pharma AG study director
Novartis Pharmaceuticals
68 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vildagliptin, Gliclazide and Metformin in people with Type 2 Diabetes Mellitus, run by Novartis Pharmaceuticals at 68 sites in 16 countries.
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 5 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 17 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Germany, Russia, Spain, United Kingdom, Tunisia and 11 more countries. 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?
Percentage of patients experiencing at least one Hypoglycaemic Event (HE) during the Ramadan fasting period to test superiority (time frame: 1 month). 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 NCT01758380, which also lists 2 linked publications.
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 17 Oct 2013.