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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1132-9716 | Other Identifier | WHO |
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This trial is conducted in Africa and Asia. The aim of the trial is to investigate the efficacy and safety of liraglutide versus sulphonylurea (SU) both in combination with metformin during Ramadan in subjects with type 2 diabetes (T2DM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liraglutide+Metformin | Experimental | Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose. |
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| Sulphonylurea and Metformin | Active Comparator | Subjects continued on pre-trial sulphonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liraglutide | Drug | 1.8 mg administered subcutaneously (s.c., under the skin) once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Fructosamine From Start of Ramadan to End of Ramadan | The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12). | Day -1, day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Fructosamine at End of Ramadan | The fructosamine values at the end of Ramadan (visit 12) were presented | Day 29 |
| Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG) | The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Algiers | 16000 | Algeria | |||
| Novo Nordisk Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27376711 | Result | Azar ST, Echtay A, Wan Bebakar WM, Al Araj S, Berrah A, Omar M, Mutha A, Tornoe K, Kaltoft MS, Shehadeh N. Efficacy and safety of liraglutide compared to sulphonylurea during Ramadan in patients with type 2 diabetes (LIRA-Ramadan): a randomized trial. Diabetes Obes Metab. 2016 Oct;18(10):1025-33. doi: 10.1111/dom.12733. Epub 2016 Aug 18. | |
| 37435938 |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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Subjects were randomised in a 1:1 manner to either switch to liraglutide 1.8 mg/day added on to metformin or to continue their pre-trial SU and metformin treatment.
The trial was conducted at 39 sites in 7 countries as follows: Algeria: 7 sites; Israel: 4 sites; India: 5 sites; Lebanon: 2 sites; Malaysia: 7 sites; South Africa: 8 sites; United Arab Emirates: 6 sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Liraglutide and Metformin | Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose. |
| FG001 | Sulfonylurea and Metformin |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| metformin | Drug | Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged |
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| sulphonylurea | Drug | Subjects will continue on their pre-trial SU tablet treatment, doses unchanged |
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| Day -1, day 29 |
| Change From Baseline to End of Ramadan in Fasting Plasma Glucose | The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate. | Baseline, day 29 |
| Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c) | The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described. | Baseline, day 29 |
| Change From Baseline to End of Ramadan in Body Weight | Baseline, day 29 |
| Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target) | Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target) | Visit 14 (4 weeks post Ramadan) |
| Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes | Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target) | Visit 14 (4 weeks post Ramadan) |
| Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period. | Day -1 to day 29 |
| Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period. | A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events. Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable | Day -1 to day 29 |
| Constantine |
| 25000 |
| Algeria |
| Novo Nordisk Investigational Site | Oran | 31000 | Algeria |
| Novo Nordisk Investigational Site | Sétif | 19000 | Algeria |
| Novo Nordisk Investigational Site | Sidi Bel Abbes | 22000 | Algeria |
| Novo Nordisk Investigational Site | Hyderabad | Andhra Pradesh | 500034 | India |
| Novo Nordisk Investigational Site | Ahmedabad | Gujarat | 380007 | India |
| Novo Nordisk Investigational Site | Bangalore | Karnataka | 560002 | India |
| Novo Nordisk Investigational Site | Mysore | Karnataka | 570001 | India |
| Novo Nordisk Investigational Site | Mysore | Karnataka | 570004 | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400008 | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400010 | India |
| Novo Nordisk Investigational Site | Mumbai | Maharashtra | 400058 | India |
| Novo Nordisk Investigational Site | Pune | Maharashtra | 411001 | India |
| Novo Nordisk Investigational Site | Beersheba | 84101 | Israel |
| Novo Nordisk Investigational Site | Haifa | 31096 | Israel |
| Novo Nordisk Investigational Site | Haifa | 35152 | Israel |
| Novo Nordisk Investigational Site | Jerusalem | 93106 | Israel |
| Novo Nordisk Investigational Site | Beirut | Lebanon |
| Novo Nordisk Investigational Site | Lebanon - Beirut | 9611 | Lebanon |
| Novo Nordisk Investigational Site | Cheras | 56000 | Malaysia |
| Novo Nordisk Investigational Site | Ipoh, Perak | 30990 | Malaysia |
| Novo Nordisk Investigational Site | Klang, Selangor | 41200 | Malaysia |
| Novo Nordisk Investigational Site | Kota Bharu, Kelantan | 16150 | Malaysia |
| Novo Nordisk Investigational Site | Putrajaya | 62250 | Malaysia |
| Novo Nordisk Investigational Site | Selangor Darul Ehsan | 68000 | Malaysia |
| Novo Nordisk Investigational Site | Seremban, Negeri Sembilan | 70400 | Malaysia |
| Novo Nordisk Investigational Site | Benoni | Gauteng | 1501 | South Africa |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 1812 | South Africa |
| Novo Nordisk Investigational Site | Johannesburg | Gauteng | 1827 | South Africa |
| Novo Nordisk Investigational Site | Lenasia | Gauteng | 1827 | South Africa |
| Novo Nordisk Investigational Site | Pretoria | Gauteng | 0181 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4091 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4092 | South Africa |
| Novo Nordisk Investigational Site | Durban | KwaZulu-Natal | 4450 | South Africa |
| Novo Nordisk Investigational Site | Ajman | 21499 | United Arab Emirates |
| Novo Nordisk Investigational Site | Dubai | 4545 | United Arab Emirates |
| Novo Nordisk Investigational Site | Dubai | 9115 | United Arab Emirates |
| Novo Nordisk Investigational Site | Ras al-Khaimah | 4727 | United Arab Emirates |
| Novo Nordisk Investigational Site | Sharjah city | 3500 | United Arab Emirates |
| Novo Nordisk Investigational Site | Umm Al Quwain City | 24 | United Arab Emirates |
| 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. |
Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
| Exposed |
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| Exposed During Ramadan (Fasting) |
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| COMPLETED |
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| NOT COMPLETED |
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Safety analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Liraglutide and Metformin | Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose. |
| BG001 | Sulfonylurea and Metformin | Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Fructosamine From Start of Ramadan to End of Ramadan | The level of fructosamine in the blood was used to assess the glycaemic control in the patients during the time period described- from start of Ramadan (day -1, visit 8) to end of Ramadan (day 29, visit 12). | Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis. | Posted | Mean | Standard Deviation | umol/L | Day -1, day 29 |
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| Secondary | Fructosamine at End of Ramadan | The fructosamine values at the end of Ramadan (visit 12) were presented | Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis. | Posted | Mean | Standard Deviation | umol/L | Day 29 |
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| Secondary | Change From Start of Ramadan to End of Ramadan in Fasting Plasma Glucose (FPG) | The level of FPG in the blood of fasting patients was addressed to monitor glycaemic control during the period described. | Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis. | Posted | Mean | Standard Deviation | mmol/L | Day -1, day 29 |
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| Secondary | Change From Baseline to End of Ramadan in Fasting Plasma Glucose | The changes from baseline measured postbaseline (i.e., the changes measured on visit 8 and 12) entered as the dependent variables, and visit, treatment, country, and the stratification variables were included as fixed factors and the corresponding values for the specific endpoint measured at randomisation as covariate. | Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis. | Posted | Mean | Standard Deviation | mmol/L | Baseline, day 29 |
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| Secondary | Change From Baseline to End of Ramadan in Glycosylated Haemoglobin (HbA1c) | The level of glycosylated haemoglobin in blood was used to assess the glycaemic control of the patients during the time period described. | Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis. | Posted | Mean | Standard Deviation | Percent (%) glycosylated haemoglobin | Baseline, day 29 |
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| Secondary | Change From Baseline to End of Ramadan in Body Weight | Full analysis set (FAS). The number of subjects in FAS were 171 (Liraglutide) and 169 (Sulfonylurea), few subjects did not contribute to this analysis. | Posted | Least Squares Mean | Standard Error | kg | Baseline, day 29 |
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| Secondary | Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol) (ADA Target) | Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target) | Full analysis set | Posted | Number | percentage (%) of subjects | Visit 14 (4 weeks post Ramadan) |
|
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| Secondary | Subjects Who at End of Treatment (4 Weeks Post Ramadan) Achieve (y/n): HbA1c Below 7.0% (53 mmol/Mol), and no Confirmed Hypoglycaemic Episodes | Subjects who at end of treatment (Visit 14, 4 weeks post Ramadan) achieve (y/n): HbA1c below 7.0% (53 mmol/mol) (ADA target) | Full analysis set | Posted | Number | percentage (%) of subjects | Visit 14 (4 weeks post Ramadan) |
|
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| Secondary | Number of Confirmed Hypoglycaemic Episodes During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period. | Safety analysis set | Posted | Number | Events/1000 years of patient exposure | Day -1 to day 29 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Treatment Emergent Adverse Events (TEAEs) During Ramadan (Fasting), Based on Each Subject's Individual Fasting Period. | A serious AE was an experience that at any dose resulted in any of the following: Death, a life-threatening experience, in-patient hospitalisation or prolongation of existing hospitalisation, a persistent or significant disability or incapacity, congenital anomaly or birth defect, important medical events. Mild - no or transient symptoms, no interference with the subject's daily activities Moderate - marked symptoms, moderate interference with the subject's daily activities Severe - considerable interference with the subject's daily activities, unacceptable | Safety analysis set | Posted | Number | Events/1000 years of patient exposure | Day -1 to day 29 |
|
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A treatment emergent AE during Ramadan (fasting) had onset on or after the individual subject's first day of Ramadan fasting, and no later than the individual subject's last day of Ramadan fasting.
Safety analysis set included all randomised subjects who were exposed to the trial drug. Subjects in the safety analysis set contributed to the evaluation 'as treated'. A total of 315 randomised subjects were exposed to trial products during Ramadan (fasting), of which 152 subjects were exposed to liraglutide and 163 subjects were exposed to SU.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liraglutide and Metformin | Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose. | 2 | 152 | 8 | 152 | ||
| EG001 | Sulfonylurea and Metformin | Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose. | 0 | 163 | 1 | 163 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess limb | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Public Access to Clinical Trials | Novo Nordisk A/S | clinicaltrials@novonordisk.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D008687 | Metformin |
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014508 | Urea |
| D000577 | Amides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
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| Male |
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| Participants |
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