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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000521-19 | EudraCT Number |
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This study was the extension of the LANTU_C_02761 study named EASIE and identified as NCT00751114 (core study comparing insulin glargine versus sitagliptin in insulin-naïve patients treated with metformin and not adequately controlled).
All patients with Glycosylated Hemoglobin A1c (HbA1c) ≥ 7% at the end of the core study had the possibility to enter this extension study if they met the other inclusion criteria and did not present with any exclusion criteria.
The visit 14 of the core study (week 24) was the visit 1 (baseline, week 0) of the extension study which consisted of a 12-week treatment period.
The objectives of this extension study were:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination insulin glargine and sitagliptin | Experimental | Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Subcutaneous injection. 100 Units/mL solution for injection in a prefilled SoloStar® pen (3 mL). |
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| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period) | study endpoint: week 12 or earlier in case of premature discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c: Change From Baseline to Study Endpoint | Change = study endpoint - baseline | baseline, study endpoint: week 12 or earlier in case of premature discontinuation |
| Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
Among the 112 included patients, two patients prematurely discontinued from the study. One of them had continued his sitagliptin treatment but never started the insulin glargine treatment.
Among the 445 patients who completed the EASIE study, 194 had an endpoint Glycosylated Hemoglobin A1c (HbA1c) ≥ 7%. A total of 112 patients were included in the extension study: 37 uncontrolled on previous treatment with metformin and insulin glargine and 75 uncontrolled on previous treatment with metformin and sitagliptin in the EASIE study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Combination Insulin Glargine and Sitagliptin | Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 \ |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sitagliptin | Drug | Oral administration. 100mg film-coated tablets. |
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| Metformin | Drug | Patients continued with metformin as usual oral anti-diabetic treatment. |
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SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Change = study endpoint - baseline. |
| baseline, study endpoint: week 12 or week 8 if value not available at week 12 |
| 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | 7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline. | baseline, study endpoint: week 12 or week 8 if value not available at week 12 |
| Insulin Dose | Daily dose at the face-to-face visits | baseline, week 4, week 8, week 12 |
| Number of Patients With at Least One Episode of Symptomatic Hypoglycemia | Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L] | During the treatment period (12 weeks) plus 7 days after last dose |
| Change in Body Weight From Baseline to Study Endpoint | Change = study endpoint - baseline | baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value |
| Vienna |
| Austria |
| Sanofi-Aventis Administrative Office | São Paulo | Brazil |
| Sanofi-Aventis Administrative Office | Bogotá | Colombia |
| Sanofi-Aventis Administrative Office | Cairo | Egypt |
| Sanofi-Aventis Administrative Office | Kallithea | Greece |
| Sanofi-Aventis Administrative Office | Hong Kong | Hong Kong |
| Sanofi-Aventis Administrative Office | Mumbai | India |
| Sanofi-Aventis Administrative Office | Netanya | Israel |
| Sanofi-Aventis Administrative Office | Beirut | Lebanon |
| Sanofi-Aventis Administrative Office | Col. Coyoacan | Mexico |
| Sanofi-Aventis Administrative Office | Gouda | Netherlands |
| Sanofi-Aventis Administrative Office | Porto Salvo | Portugal |
| Sanofi-Aventis Administrative Office | Seoul | South Korea |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Guildford Surrey | United Kingdom |
| Safety Population |
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| Treated by Combination |
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| Modified Intent-To-Treat Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Combination Insulin Glargine and Sitagliptin | Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \ |
| 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 | mITT population Age collected at EASIE study entry (24 weeks before baseline) | Mean | Standard Deviation | years |
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| Sex: Female, Male | mITT population | Count of Participants | Participants |
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| Body Weight | mITT population | Mean | Standard Deviation | kg |
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| Body Mass Index | mITT population | Mean | Standard Deviation | kg/m² |
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| Systolic Blood Pressure | mITT population | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | mITT population | Mean | Standard Deviation | mmHg |
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| Heart Rate | mITT population | Mean | Standard Deviation | beats/min |
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| Duration of diabetes | mITT population Duration of diabetes collected at EASIE study entry (24 weeks before baseline) | Median | Inter-Quartile Range | years |
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| At least one diabetic late complication | mITT population Diabetic late complications: myocardial infarction, angina pectoris, coronary artery disease, heart failure, stroke, transient ischemic attack, peripheral vascular disease, diabetic neuropathy, diabetic nephropathy, diabetic retinopathy Information collected at EASIE study entry (24 weeks before baseline) | Number | participants |
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| Glycosylated Hemoglobin A1c (HbA1c) | mITT population | Mean | Standard Deviation | percent |
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| Fasting Plasma Glucose | mITT population but due to missing values N=110 | Mean | Standard Deviation | mg/dL |
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| Self-Monitored Fasting Plasma Glucose | mITT population but due to missing values N=104 | Mean | Standard Deviation | mg/dL |
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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 | HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period) | The population analyzed consisted of the subset of mITT patients who had HbA1c value at study endpoint. | Posted | Number | 95% Confidence Interval | percentage of participants | study endpoint: week 12 or earlier in case of premature discontinuation |
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| Secondary | HbA1c: Change From Baseline to Study Endpoint | Change = study endpoint - baseline | The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure | Posted | Mean | Standard Deviation | percent | baseline, study endpoint: week 12 or earlier in case of premature discontinuation |
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| Secondary | Self-Monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint | SMFPG mean = mean of the fasting plasma glucose values recorded on the 6 consecutive days before the visit (at least 3 values needed). Change = study endpoint - baseline. | The population analyzed consisted of the subset of mITT patients who had both baseline and endpoint for this outcome measure | Posted | Mean | Standard Deviation | mg/dL | baseline, study endpoint: week 12 or week 8 if value not available at week 12 |
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| Secondary | 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint | 7-point plasma glucose recorded before and after breakfast, before and after lunch, before and after dinner and at bedtime. Change = study endpoint - baseline. | The population analyzed consisted of the subset of mITT patients who had valid 7-point plasma glucose profiles (4 points needed for a valid profile) both at baseline and endpoint. Depending on the time point, few values were missing. | Posted | Mean | Standard Deviation | mg/dL | baseline, study endpoint: week 12 or week 8 if value not available at week 12 |
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| Secondary | Insulin Dose | Daily dose at the face-to-face visits | mITT population | Posted | Mean | Standard Deviation | unit per kg body weight | baseline, week 4, week 8, week 12 |
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| Secondary | Number of Patients With at Least One Episode of Symptomatic Hypoglycemia | Symptomatic hypoglycemia was defined as an event with clinical symptoms that were considered to result from hypoglycemia confirmed or not by a plasma glucose measurement <= 70mg/dL [3.9 mmol/L] | The population analyzed for this outcome measure was the safety population | Posted | Number | participants | During the treatment period (12 weeks) plus 7 days after last dose |
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| Secondary | Change in Body Weight From Baseline to Study Endpoint | Change = study endpoint - baseline | The population analyzed was the safety population with both baseline and endpoint values available | Posted | Mean | Standard Deviation | kg | baseline, study endpoint: week 12 or week 8 or week 4 depending on last available value |
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Adverse events were assessed throughout the extension study (12 weeks). Only adverse events starting from inclusion in the extension study were taken into account.
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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 | Combination Insulin Glargine and Sitagliptin | Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 \ | 2 | 112 | 0 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Right ventricular failure | Cardiac disorders | MedDra | Non-systematic Assessment |
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| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra | Non-systematic Assessment |
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If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 45 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | sanofi-aventis | Contact-US@sanofi.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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