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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-000516-32 | EudraCT Number |
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The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period.
Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:
Safety objectives consisted of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Glargine | Experimental | Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\ |
|
| Sitagliptin | Active Comparator | Dose of 100 mg once a day administered with or without food. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL). |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c: Change From Baseline to Study Endpoint | Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period. | baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint | study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 | |
| HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22683131 | Result | Aschner P, Chan J, Owens DR, Picard S, Wang E, Dain MP, Pilorget V, Echtay A, Fonseca V; EASIE investigators. Insulin glargine versus sitagliptin in insulin-naive patients with type 2 diabetes mellitus uncontrolled on metformin (EASIE): a multicentre, randomised open-label trial. Lancet. 2012 Jun 16;379(9833):2262-9. doi: 10.1016/S0140-6736(12)60439-5. Epub 2012 Jun 9. | |
| 25283485 |
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A total of 732 patients were screened in 96 centers in 17 countries. The study included an initial 2-week screening period. A total of 217 patients were screen failures. The main reason for screen failure was Glycosylated Hemoglobin A1c (HbA1c) inclusion criterion not met (146 patients).
EASIE was a multicenter, international, randomized, open-label trial conducted from November 12, 2008 to July 28, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Insulin Glargine | Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the Fasting Plasma Glucose (FPG) target: 70mg/dL\ |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sitagliptin | Drug | Oral administration. 100 mg film-coated tablets. |
|
|
| Metformin | Drug | Patients continued with metformin as usual oral anti-diabetic treatment. |
|
| study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
| 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). Study endpoint was defined as the last available SMFPG mean value collected on-treatment. Change= study endpoint - baseline | baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value |
| 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 (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
| Insulin Dose in the Insulin Glargine Group | Daily dose at the face-to-face visits. | visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value |
| Lipid Profile: Change From Baseline to Study Endpoint | baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
| Change in Body Weight From Baseline to Study Endpoint | baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value |
| 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 phase (24 weeks) plus 7 days after last dose |
| Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia | Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration | During the treatment phase (24 weeks) plus 7 days after last dose |
| 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 | Istanbul | Turkey (Türkiye) |
| Sanofi-Aventis Administrative Office | Guildford Surrey | United Kingdom |
| Chan JC, Aschner P, Owens DR, Picard S, Vincent M, Dain MP, Pilorget V, Loizeau V, Echtay A, Fonseca V. Triple combination of insulin glargine, sitagliptin and metformin in type 2 diabetes: the EASIE post-hoc analysis and extension trial. J Diabetes Complications. 2015 Jan-Feb;29(1):134-41. doi: 10.1016/j.jdiacomp.2014.08.007. Epub 2014 Aug 27. |
| Sitagliptin |
Dose of 100 mg once a day administered with or without food |
| TREATED = Safety Population |
|
| mITT Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Glargine | Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\ |
| BG001 | Sitagliptin | Dose of 100 mg once a day administered with or without food |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | mITT population | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex/Gender, Customized | mITT population | Number | participants |
| |||||||||||||||
| Body Weight | mITT population | Mean | Standard Deviation | kg |
| ||||||||||||||
| Body Mass Index | mITT population | Mean | Standard Deviation | kg/m² |
| ||||||||||||||
| Systolic Blood Pressure | mITT population | Mean | Standard Deviation | mmHg |
| ||||||||||||||
| Diastolic Blood Pressure | mITT population | Mean | Standard Deviation | mmHg |
| ||||||||||||||
| Heart Rate | mITT population | Mean | Standard Deviation | beats/min |
| ||||||||||||||
| Duration of diabetes | mITT population | Median | Inter-Quartile Range | years |
| ||||||||||||||
| 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 | Number | participants |
| |||||||||||||||
| Glycosylated Hemoglobin A1c (HbA1c) | mITT population | Mean | Standard Deviation | percent |
| ||||||||||||||
| Fasting Plasma Glucose | mITT population but due to missing values, N=225 for Insulin Glargine and N=248 for Sitagliptin | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Self-monitored Fasting Plasma Glucose | mITT population but due to missing values, N=216 for Insulin Glargine and N=244 for Sitagliptin | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Total Cholesterol | mITT population but due to missing values, N=225 for Insulin Glargine and N=248 for Sitagliptin | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| High-Density Lipoprotein (HDL) Cholesterol | mITT population but due to missing values, N=225 for Insulin Glargine and N=248 for Sitagliptin | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Low-Density Lipoprotein (LDL) Cholesterol | mITT population but due to missing values, N=225 for Insulin Glargine and N=248 for Sitagliptin | Mean | Standard Deviation | mg/dL |
| ||||||||||||||
| Triglycerides | mITT population but due to missing values, N=225 for Insulin Glargine and N=248 for Sitagliptin | 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: Change From Baseline to Study Endpoint | Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period. | The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements. The Last Observation Carried Forward method was used for imputing missing data for the end of treatment value. | Posted | Least Squares Mean | Standard Error | percent | baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
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| Secondary | HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint | The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements. | Posted | Number | percentage of participants | study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
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| Secondary | HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint | The population analyzed for this outcome measure consisted of the subset of mITT patients who had endpoint measurements. | Posted | Number | percentage of participants | study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
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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). Study endpoint was defined as the last available SMFPG mean value collected on-treatment. Change= study endpoint - baseline | The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements. Adjusted means were estimated from ANCOVA model using baseline value as covariate. | Posted | Least Squares Mean | Standard Error | mg/dL | baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value |
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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 for this outcome measure 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. Adjusted means were estimated from ANCOVA model using baseline value as covariate. | Posted | Least Squares Mean | Standard Error | mg/dL | baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
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| Secondary | Insulin Dose in the Insulin Glargine Group | Daily dose at the face-to-face visits. | The population analyzed for this outcome was the safety population defined as randomized patients who received at least one dose of investigational product. | Posted | Mean | Standard Deviation | unit per kg body weight | visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value |
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| Secondary | Lipid Profile: Change From Baseline to Study Endpoint | The population analyzed for this outcome measure consisted of the subset of mITT patients who had both baseline and endpoint measurements. Adjusted means were estimated from ANCOVA model using baseline value as covariate. | Posted | Least Squares Mean | Standard Error | mg/dL | baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14 |
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| Secondary | Change in Body Weight From Baseline to Study Endpoint | The population analyzed for this outcome measure consisted of the subset of the safety population (treated patients) who had both baseline and endpoint measurements. Adjusted means were estimated from ANCOVA model using baseline value as covariate. | Posted | Least Squares Mean | Standard Error | kg | baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value |
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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 (treated patients) | Posted | Number | participants | During the treatment phase (24 weeks) plus 7 days after last dose |
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| Secondary | Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia | Severe symptomatic hypoglycemia was defined as an event with clinical symptoms which required assistance of another person and with either a Plasma Glucose level < 36 mg/dL (2 mmol/L) or with a prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration | The population analyzed for this outcome measure was the safety population (treated patients) | Posted | Number | participants | During the treatment phase (24 weeks) plus 7 days after last dose |
|
|
Adverse events were assessed throughout the study (24 weeks). Mean duration of exposure to insulin glargine was 157.7 ± 40.9 days (ranging from 1 to 211 days) and 160.8 ± 33.7 days to sitagliptin (ranging from 14 to 262 days).
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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 | Insulin Glargine | Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\ | 15 | 237 | 27 | 237 | ||
| EG001 | Sitagliptin | Dose of 100 mg once a day administered with or without food | 8 | 264 | 41 | 264 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anaemia | Blood and lymphatic system disorders | MedDra | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDra | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDra | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDra | Non-systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDra | Non-systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDra | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDra | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDra | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDra | Non-systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDra | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDra | Non-systematic Assessment |
| |
| Hypoglycaemic unconsciousness | Metabolism and nutrition disorders | MedDra | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra | Non-systematic Assessment |
| |
| Kaposi's sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra | Non-systematic Assessment |
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| Carotid artery occlusion | Nervous system disorders | MedDra | Non-systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDra | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDra | Non-systematic Assessment |
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| Nerve compression | Nervous system disorders | MedDra | Non-systematic Assessment |
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| Calculus ureteric | Renal and urinary disorders | MedDra | Non-systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDra | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDra | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDra | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDra | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDra | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | 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 |
Not provided
Not provided
| Female |
|
| No |
|
Difference (Insulin glargine - Sitagliptin) |
| No |
| Superiority or Other |
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| Participants |
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| Participants |
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