Type 2 Diabetes
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGSulfonylurea
The dose and frequency of administration of study drug (sulfonylurea) was decided by the investigator according to the individual need of each participant.
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with Type 2 Diabetes, of either gender and aged between 18-75 years * Patients being considered for addition of Sulfonylurea on background of at least one other oral hypoglycemic agent, on a usual visit (screening cum enrolment visit), as per the clinical situation judged by participating physician * Willing to comply with study requirements
Exclusion criteria
* Patients with type 1 Diabetes or gestational Diabetes * Patients currently on insulin therapy or have received Insulin in last 6 months * Patients currently on Sulfonylurea therapy or have received Sulfonylureas in last 6 months * Patients currently on Meglitinides therapy or have received Meglitinides in last 6 months * Patients initiated on Sulfonylurea monotherapy * Patient on DPP-4 inhibitors, either as monotherapy or as combination therapy * Patient is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence. * Patients for whom it would be impossible to complete the questionnaire for whatever reason, in any feasible form * Patients who are already participating in a clinical trial or other clinical study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores | Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Week 12 | 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. |
| Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Week 12 | 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. |
| Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12 | Baseline and 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral
hypoglycemic agent(s). | 1,069 |
| Total | 1,069 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 59 |
| Overall Study | Missing discontinuation information | 15 |
| Overall Study | Noncompliance | 5 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 52.21 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment India | 1069 participants |
| Sex/Gender, Customized Female | 472 participants |
| Sex/Gender, Customized Male | 589 participants |
| Sex/Gender, Customized Missing | 8 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 492 / 1,069 |
| serious Total, serious adverse events | 0 / 1,069 |
Outcome results
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores | -0.1215 Correlation coefficient | 95% Confidence Interval 1.9 |
p-value: 0.0002Regression, Linear
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.
Time frame: Baseline and Week 12
Population: All enrolled participants with available data at both Baseline and Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Correlation Between HbA1c Values at Baseline and Hypoglycemia Scores at Week 12 | 0.0026 Correlation coefficient |
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.
Time frame: Week 12
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Male, n=526 | -0.1654 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Female, n=417 | -0.0756 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Age 18-34 years, n=45 | -0.1636 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Age 35-44 years, n=171 | -0.1034 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Age 45-64 years, n=595 | -0.1222 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Age 65 years and older, n=138 | -0.0984 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Body mass index <25 kg/m^2, n=370 | -0.0100 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Body mass index 25-30 kg/m^2, n=394 | -0.2188 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Body mass index >30 kg/m^2, n=183 | -0.1688 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Duration of diabetes <5 years, n=640 | -0.1201 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Duration of diabetes 5-10 years, n=239 | -0.1503 Correlation coefficient |
| All Participants | Correlation Between HbA1c Values at Week 12 and Hypoglycemia Scores by Sub-group (Demographic/Disease Parameters) | Duration of diabetes >10 years, n=49 | -0.1316 Correlation coefficient |
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.
Time frame: Week 12
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | No background oral hypoglycemic agents, n=20 | 0.60 Score on a scale | Standard Deviation 0.99 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Male, n=526 | 0.87 Score on a scale | Standard Deviation 1.37 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Female, n=417 | 1.12 Score on a scale | Standard Deviation 1.46 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Age 18-34 years, n=45 | 0.91 Score on a scale | Standard Deviation 1.62 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Age 35-44 years, n=171 | 0.87 Score on a scale | Standard Deviation 1.36 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Age 45-64 years, n=595 | 0.96 Score on a scale | Standard Deviation 1.39 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Age 65 years and older, n=138 | 1.18 Score on a scale | Standard Deviation 1.49 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Mild hypoglycemia, n=286 | 1.59 Score on a scale | Standard Deviation 1.38 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Moderate hypoglycemia, n=168 | 2.36 Score on a scale | Standard Deviation 1.49 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Severe hypoglycemia, n=15 | 2.53 Score on a scale | Standard Deviation 1.68 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Body mass index <25 kg/m^2, n=370 | 1.01 Score on a scale | Standard Deviation 1.44 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Body mass index 25-30 kg/m^2, n=394 | 0.95 Score on a scale | Standard Deviation 1.42 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Body mass index >30 kg/m^2, n=183 | 0.96 Score on a scale | Standard Deviation 1.37 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Duration of T2DM <5 years, n=640 | 0.88 Score on a scale | Standard Deviation 1.36 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Duration of T2DM 5-10 years, n=239 | 1.15 Score on a scale | Standard Deviation 1.52 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | Duration of T2DM >10 years, n=49 | 1.29 Score on a scale | Standard Deviation 1.46 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | 1 background oral hypoglycemic agent, n=854 | 0.97 Score on a scale | Standard Deviation 1.41 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | 2 background oral hypoglycemic agents, n=69 | 1.30 Score on a scale | Standard Deviation 1.61 |
| All Participants | Hypoglycemia Symptom Score by Sub-group (Demographic/Disease Parameters) | 3 background oral hypoglycemic agents, n=7 | 0.00 Score on a scale | Standard Deviation 0 |