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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_001 |
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This study will assess the correlation between glycemic control and the hypoglycemia symptom score in patients with Type 2 diabetes, 12 weeks after addition of a sulfonylurea to an ongoing regime of oral hypoglycemic agents.
Patients will be evaluated for participation in the study during their usual visit to participating diabetes care clinics. Addition of sulfonylurea will be an unbiased decision of the participating physicians based on the clinical needs of the participating patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All participants | Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulfonylurea | Drug | The dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores | Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12. |
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Inclusion Criteria:
Exclusion Criteria:
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Diabetic clinic patients
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23289432 | Background | Kalra S, Deepak MC, Narang P, Singh V, Uvaraj MG, Agrawal N. Usage pattern, glycemic improvement, hypoglycemia, and body mass index changes with sulfonylureas in real-life clinical practice: results from OBSTACLE Hypoglycemia Study. Diabetes Technol Ther. 2013 Feb;15(2):129-35. doi: 10.1089/dia.2012.0237. Epub 2013 Jan 5. | |
| 24823514 |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral hypoglycemic agent(s). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age was missing for 1 participant; therefore, the population for age included 1068 participants. |
| 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 | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores | Coefficient of correlation was measured using a linear regression analysis for the association between two variables, HbA1c values at Week 12 and hypoglycemia scores. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa. | Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation. | Posted | Number | 95% Confidence Interval | Correlation coefficient | Week 12 |
|
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No adverse events were recorded separately other than hypoglycemia.
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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 | All Participants |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 13.1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.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 |
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| ID | Term |
|---|---|
| D013453 | Sulfonylurea Compounds |
| ID | Term |
|---|---|
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Week 12 |
| Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa. | Week 12 |
| Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12 | Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases. | Baseline and Week 12 |
| Kalra S, Deepak MC, Narang P, Singh V, Maheshwari A. Correlation between measures of hypoglycemia and glycemic improvement in sulfonylurea treated patients with type 2 diabetes in India: results from the OBSTACLE hypoglycemia study. J Postgrad Med. 2014 Apr-Jun;60(2):151-5. doi: 10.4103/0022-3859.132322. |
| Protocol Violation |
|
| Missing discontinuation information |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Sub-group analyses of mean hypoglycemia symptom score. Participants were grouped based on gender, age, hypoglycemia severity, body mass index, duration of diabetes, and number of oral hypoglycemic agents. Hypoglycemia symptom score (measured by Stanford Hypoglycemia Questionnaire) is a score on a scale with a possible range of 0 (best) to 7 (worst). The questionnaire was administered by the physician at Week 12. | Evaluable population defined as all enrolled participants who completed the study and had the values for HbA1c at Week 12 and Stanford Hypoglycemia Score without any major protocol deviation. | Posted | Mean | Standard Deviation | Score on a scale | Week 12 |
|
|
|
| Secondary | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Sub-group analyses based on Karl pearson coefficient of correlation for HbA1c values at Week 12 and hypoglycemia score. Participants were grouped based on gender, age, body mass index, and duration of diabetes. A negative correlation coefficient indicates that as one value increases the other value decreases, and vice versa. | Posted | Number | Correlation coefficient | Week 12 |
|
|
|
| Secondary | Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12 | Coefficient of correlation as measured using linear regression analysis for association between two variables, HbA1c values at baseline and hypoglycemia scores. A positive correlation coefficient indicates that as one value increases the other value increases, or as as one value decreases the other value decreases. | All enrolled participants with available data at both Baseline and Week 12. | Posted | Number | Correlation coefficient | Baseline and Week 12 |
|
|
|
| 0 |
| 1,069 |
| 492 |
| 1,069 |
The study sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the study sponsor as confidential must be deleted prior to submission.
| D004700 | Endocrine System Diseases |
| Sulfur Compounds |
| Title | Measurements |
|---|---|
|
| Age 35-44 years, n=171 |
|
| Age 45-64 years, n=595 |
|
| Age 65 years and older, n=138 |
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| Mild hypoglycemia, n=286 |
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| Moderate hypoglycemia, n=168 |
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| Severe hypoglycemia, n=15 |
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| Body mass index <25 kg/m^2, n=370 |
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| Body mass index 25-30 kg/m^2, n=394 |
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| Body mass index >30 kg/m^2, n=183 |
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| Duration of T2DM <5 years, n=640 |
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| Duration of T2DM 5-10 years, n=239 |
|
| Duration of T2DM >10 years, n=49 |
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| No background oral hypoglycemic agents, n=20 |
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| 1 background oral hypoglycemic agent, n=854 |
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| 2 background oral hypoglycemic agents, n=69 |
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| 3 background oral hypoglycemic agents, n=7 |
|
| Title | Measurements |
|---|---|
|
| Age 35-44 years, n=171 |
|
| Age 45-64 years, n=595 |
|
| Age 65 years and older, n=138 |
|
| Body mass index <25 kg/m^2, n=370 |
|
| Body mass index 25-30 kg/m^2, n=394 |
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| Body mass index >30 kg/m^2, n=183 |
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| Duration of diabetes <5 years, n=640 |
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| Duration of diabetes 5-10 years, n=239 |
|
| Duration of diabetes >10 years, n=49 |
|