Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in Asia, South America and the United States of America (USA). The aim of this clinical trial is to determine whether two insulin treatments given once daily are equally effective with respect to the blood glucose lowering effect in subjects with type 2 diabetes inadequately controlled on metformin treatment with or without an additional anti-diabetic drug (OAD).
Interventions
DRUGinsulin detemir
Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued
DRUGinsulin glargine
Treat-to-target (individually adjusted dose) titration according to titration algorithm. S.c. (under the skin) injection once daily as an add-on to subjects' stable pre-trial metformin dose (at least 1500 mg/day). Any other use of OAD will be discontinued
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 2 diabetes for at least 6 months * Stable treatment with a total daily dose of at least 1500 mg metformin or maximum tolerated dose (minimum 1000 mg) with or without one other OAD (sulphonylureas, meglitinides, thiazolidinediones or dipeptidyl peptidase-4 (DPP-4) inhibitors) for at least 3 months * Subject is insulin-naive (short-term insulin treatment of up to 14 days is allowed) * HbA1c (glycosylated haemoglobin) 7.0-9.0 % (both inclusive) by central laboratory analysis (one re-test within one week is allowed) * Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2
Exclusion criteria
* Any contraindication to insulin detemir or insulin glargine according to the local labelling * Receipt of any investigational product within 4 weeks * Anticipated change of dose of any systemic treatment with products, which in the Investigator's opinion could interfere with glucose metabolism (e.g. systemic corticosteroids) * Clinically significant diseases which, in the Investigator's opinion may confound the results of the trial or pose additional risk in administering trial product * Any other condition that the Investigator feels would interfere with trial participation or evaluation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c From Baseline | Week 0, Week 26 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | Week 26 | The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. |
| Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | Week 26 | The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less |
| Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | Week 26 | The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment. |
| Fasting Plasma Glucose (FPG) | Week 26 | — |
| Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Week 26 | The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time. |
| Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Week 26 | Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am. |
| Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | Week 26 | The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7% |
| Hypoglycaemic Episodes, Diurnal | Weeks 0-26 | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
| Hypoglycaemic Episodes, Nocturnal | Weeks 0-26 | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
| Hypoglycemic Episodes, Unclassifiable | Weeks 0-26 | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
| Change in Body Weight From Baseline | Week 0, Week 26 | — |
| Number of Subjects Having the Adverse Event Incorrect Dose Administered | Weeks 0-26 | Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications |
| Incidence of Hypoglycaemic Episodes During the Trial | Weeks 0-26 | Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L. |
Countries
Argentina, India, Puerto Rico, South Korea, Thailand, United States
Participant flow
Recruitment details
There were a total of 85 trial sites in 5 countries: 70 in the United States of America (USA), 5 in Thailand, 4 in Korea, 2 in India and 4 in Argentina
Pre-assignment details
After randomisation, the dose and dosing frequency of metformin were maintained throughout the trial in both treatment arms. Other oral anti-diabetic drug (OAD) was discontinued before use of trial product
Participants by arm
| Arm | Count |
|---|---|
| IDet Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day | 226 |
| IGlar Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day | 227 |
| Total | 453 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 3 |
| Overall Study | Protocol Violation | 6 | 8 |
| Overall Study | Unclassified | 18 | 19 |
| Overall Study | Withdrawal criteria | 9 | 11 |
Baseline characteristics
| Characteristic | Total | IGlar | IDet |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 10.2 | 57.3 years STANDARD_DEVIATION 10.3 | 57.3 years STANDARD_DEVIATION 10.2 |
| Body Mass Index (BMI) | 28.96 kg/m^2 STANDARD_DEVIATION 3.93 | 29.06 kg/m^2 STANDARD_DEVIATION 3.9 | 28.86 kg/m^2 STANDARD_DEVIATION 3.96 |
| Diabetes History | 8.22 years STANDARD_DEVIATION 6.08 | 8.44 years STANDARD_DEVIATION 6.56 | 7.99 years STANDARD_DEVIATION 5.56 |
| Fasting Plasma Glucose (FPG) | 8.56 mmol/L STANDARD_DEVIATION 2.24 | 8.46 mmol/L STANDARD_DEVIATION 2.21 | 8.66 mmol/L STANDARD_DEVIATION 2.26 |
| HbA1c (Glycosylated haemoglobin A1c) | 7.91 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 0.6 | 7.86 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 0.58 | 7.96 Percent (%) glycosylated haemoglobin STANDARD_DEVIATION 0.62 |
| Height | 1.68 meters STANDARD_DEVIATION 0.11 | 1.67 meters STANDARD_DEVIATION 0.1 | 1.69 meters STANDARD_DEVIATION 0.11 |
| Race/Ethnicity, Customized American Indian/Alaska Native | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Asian | 116 participants | 60 participants | 56 participants |
| Race/Ethnicity, Customized Black/African American | 53 participants | 31 participants | 22 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 107 participants | 56 participants | 51 participants |
| Race/Ethnicity, Customized Native Hawaiian or pacific islander | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Not Applicable | 32 participants | 21 participants | 11 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 314 participants | 150 participants | 164 participants |
| Race/Ethnicity, Customized Other | 14 participants | 7 participants | 7 participants |
| Race/Ethnicity, Customized White | 267 participants | 129 participants | 138 participants |
| Region of Enrolment Argentina | 21 participants | 10 participants | 11 participants |
| Region of Enrolment India | 51 participants | 32 participants | 19 participants |
| Region of Enrolment Korea, Republic of | 26 participants | 10 participants | 16 participants |
| Region of Enrolment Thailand | 33 participants | 16 participants | 17 participants |
| Region of Enrolment United States | 322 participants | 159 participants | 163 participants |
| Sex: Female, Male Female | 198 Participants | 101 Participants | 97 Participants |
| Sex: Female, Male Male | 255 Participants | 126 Participants | 129 Participants |
| Stratification Metformin monotherapy | 124 participants | 62 participants | 62 participants |
| Stratification Metformin + other OAD other than TZD | 299 participants | 150 participants | 149 participants |
| Stratification Metformin+thiazolidinedione (TZD) | 30 participants | 15 participants | 15 participants |
| Weight | 82.3 kg STANDARD_DEVIATION 16.7 | 81.7 kg STANDARD_DEVIATION 16.2 | 82.8 kg STANDARD_DEVIATION 17.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 226 | 18 / 227 |
| serious Total, serious adverse events | 7 / 226 | 12 / 227 |
Outcome results
Primary
Change in HbA1c From Baseline
Time frame: Week 0, Week 26
Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDet | Change in HbA1c From Baseline | -0.48 percentage point change | Standard Deviation 0.94 |
| IGlar | Change in HbA1c From Baseline | -0.74 percentage point change | Standard Deviation 0.76 |
95% CI: [0.1427, 0.458]ANCOVA
Secondary
Change in Body Weight From Baseline
Time frame: Week 0, Week 26
Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDet | Change in Body Weight From Baseline | -0.49 kg | Standard Deviation 3.31 |
| IGlar | Change in Body Weight From Baseline | 1 kg | Standard Deviation 3.07 |
Secondary
Fasting Plasma Glucose (FPG)
Time frame: Week 26
Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDet | Fasting Plasma Glucose (FPG) | 6.22 mmol/L | Standard Deviation 1.88 |
| IGlar | Fasting Plasma Glucose (FPG) | 6.09 mmol/L | Standard Deviation 2.38 |
Secondary
Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles)
Plasma glucose measured: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, bedtime and at 3 am.
Time frame: Week 26
Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Before breakfast (N=200, N=197) | 5.8 mmol/L | Standard Deviation 1.5 |
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Before Dinner (N=194, N=186) | 8.2 mmol/L | Standard Deviation 2.6 |
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Before Lunch (N=193, N=189) | 7.2 mmol/L | Standard Deviation 2.8 |
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | 2 hours after dinner (N=192, N=190) | 10.3 mmol/L | Standard Deviation 3 |
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | 2 hours after breakfast (N=192, N=188) | 9.1 mmol/L | Standard Deviation 2.9 |
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Bedtime (N=190, N=183) | 9.5 mmol/L | Standard Deviation 3.2 |
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | 2 hours After Lunch (N=194, N=186) | 9.7 mmol/L | Standard Deviation 3.2 |
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | At 3AM (N=193, N=186) | 6.6 mmol/L | Standard Deviation 2.5 |
| IDet | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Before Breakfast Next Day (N=197, N=195) | 5.7 mmol/L | Standard Deviation 1.7 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | At 3AM (N=193, N=186) | 6.3 mmol/L | Standard Deviation 2.1 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Before Breakfast Next Day (N=197, N=195) | 5.6 mmol/L | Standard Deviation 1.7 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Before breakfast (N=200, N=197) | 5.9 mmol/L | Standard Deviation 1.9 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | 2 hours after breakfast (N=192, N=188) | 8.7 mmol/L | Standard Deviation 2.8 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Before Lunch (N=193, N=189) | 6.6 mmol/L | Standard Deviation 2.2 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | 2 hours After Lunch (N=194, N=186) | 8.8 mmol/L | Standard Deviation 2.9 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Before Dinner (N=194, N=186) | 7.5 mmol/L | Standard Deviation 2.5 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | 2 hours after dinner (N=192, N=190) | 9.8 mmol/L | Standard Deviation 2.8 |
| IGlar | Glycaemic Control as Measured by Plasma Glucose (9-point Self-measured Profiles) | Bedtime (N=190, N=183) | 9 mmol/L | Standard Deviation 3.1 |
Secondary
Hypoglycaemic Episodes, Diurnal
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-26
Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDet | Hypoglycaemic Episodes, Diurnal | Major | 0 episodes |
| IDet | Hypoglycaemic Episodes, Diurnal | Minor | 75 episodes |
| IDet | Hypoglycaemic Episodes, Diurnal | Symptoms only | 128 episodes |
| IGlar | Hypoglycaemic Episodes, Diurnal | Major | 2 episodes |
| IGlar | Hypoglycaemic Episodes, Diurnal | Minor | 118 episodes |
| IGlar | Hypoglycaemic Episodes, Diurnal | Symptoms only | 222 episodes |
Secondary
Hypoglycaemic Episodes, Nocturnal
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-26
Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDet | Hypoglycaemic Episodes, Nocturnal | Major | 0 episodes |
| IDet | Hypoglycaemic Episodes, Nocturnal | Minor | 39 episodes |
| IDet | Hypoglycaemic Episodes, Nocturnal | Symptoms only | 76 episodes |
| IGlar | Hypoglycaemic Episodes, Nocturnal | Major | 0 episodes |
| IGlar | Hypoglycaemic Episodes, Nocturnal | Minor | 30 episodes |
| IGlar | Hypoglycaemic Episodes, Nocturnal | Symptoms only | 61 episodes |
Secondary
Hypoglycemic Episodes, Unclassifiable
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-26
Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDet | Hypoglycemic Episodes, Unclassifiable | Major | 0 episodes |
| IDet | Hypoglycemic Episodes, Unclassifiable | Minor | 5 episodes |
| IDet | Hypoglycemic Episodes, Unclassifiable | Symptoms only | 6 episodes |
| IGlar | Hypoglycemic Episodes, Unclassifiable | Major | 0 episodes |
| IGlar | Hypoglycemic Episodes, Unclassifiable | Minor | 8 episodes |
| IGlar | Hypoglycemic Episodes, Unclassifiable | Symptoms only | 16 episodes |
Secondary
Incidence of Hypoglycaemic Episodes During the Trial
Number of hypoglycaemic episodes from Week 0 to Week 26, defined as major, minor, or symptoms only. Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Symptoms only if able to treat her/himself and no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.
Time frame: Weeks 0-26
Population: Safety Analysis Set is all randomised subjects exposed to at least one dose of trial product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDet | Incidence of Hypoglycaemic Episodes During the Trial | All Events | 329 episodes |
| IDet | Incidence of Hypoglycaemic Episodes During the Trial | Major | 0 episodes |
| IDet | Incidence of Hypoglycaemic Episodes During the Trial | Minor | 119 episodes |
| IDet | Incidence of Hypoglycaemic Episodes During the Trial | Symptoms only | 210 episodes |
| IGlar | Incidence of Hypoglycaemic Episodes During the Trial | Symptoms only | 299 episodes |
| IGlar | Incidence of Hypoglycaemic Episodes During the Trial | All Events | 457 episodes |
| IGlar | Incidence of Hypoglycaemic Episodes During the Trial | Minor | 156 episodes |
| IGlar | Incidence of Hypoglycaemic Episodes During the Trial | Major | 2 episodes |
Secondary
Number of Subjects Having the Adverse Event Incorrect Dose Administered
Number of subjects having the adverse event incorrect dose administered within the system organ class Injury, poisoning and procedural complications
Time frame: Weeks 0-26
Population: Safety Analysis Set: All subjects that received at least one dose of the trial product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDet | Number of Subjects Having the Adverse Event Incorrect Dose Administered | 12 Subjects |
| IGlar | Number of Subjects Having the Adverse Event Incorrect Dose Administered | 24 Subjects |
Secondary
Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5%
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c of 6.5% or less
Time frame: Week 26
Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDet | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | Metformin monotherapy | 22 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | Metformin+TZD | 13 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | Metformin+2nd OAD other than TZD | 5 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | All | 11 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | All | 21 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | Metformin monotherapy | 30 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | Metformin+2nd OAD other than TZD | 17 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c Less Than or Equal to 6.5% | Metformin+TZD | 13 percentage (%) of subjects |
Secondary
Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0%
The percentage of subjects - overall and by previous OAD treatment - meeting the HbA1c less than or equal to 7%
Time frame: Week 26
Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDet | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | Metformin monotherapy | 55 percentage of subjects |
| IDet | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | Metformin+TZD | 40 percentage of subjects |
| IDet | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | Metformin+2nd OAD other than TZD | 31 percentage of subjects |
| IDet | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | All | 38 percentage of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | All | 53 percentage of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | Metformin monotherapy | 70 percentage of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | Metformin+2nd OAD other than TZD | 47 percentage of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c Less Than or Equal to 7.0% | Metformin+TZD | 40 percentage of subjects |
Secondary
Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.
Time frame: Week 26
Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDet | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | Metformin monotherapy | 22 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | Metformin+TZD | 7 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | Metformin+2nd OAD other than TZD | 3 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | All | 9 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | All | 15 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | Metformin monotherapy | 21 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | Metformin+2nd OAD other than TZD | 13 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c of 6.5% or Less With no Hypoglycaemia | Metformin+TZD | 13 percentage (%) of subjects |
Secondary
Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia
The subjects must have reached target and not have experienced any confirmed symptomatic hypoglycaemia or any confirmed major hypoglycaemia within the last 30 days of treatment.
Time frame: Week 26
Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDet | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | Metformin monotherapy | 48 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | Metformin+TZD | 33 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | Metformin+2nd OAD other than TZD | 25 percentage (%) of subjects |
| IDet | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | All | 32 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | All | 38 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | Metformin monotherapy | 52 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | Metformin+2nd OAD other than TZD | 33 percentage (%) of subjects |
| IGlar | Percentage of Subjects Achieving HbA1c of 7% or Less With no Hypoglycaemia | Metformin+TZD | 33 percentage (%) of subjects |
Secondary
Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast
The median values of the sample standard variation (the within subject variation) within the IDet and IGlar arms were plotted against time.
Time frame: Week 26
Population: Full analysis set: All randomised subjects exposed to at least one dose of trial product categorised by randomised treatment.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDet | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Metformin Monotherapy | 0.48 mmol/L |
| IDet | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Metformin+TZD | 0.72 mmol/L |
| IDet | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Metformin+2nd OAD other than TZD | 0.6 mmol/L |
| IDet | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Overall | 0.57 mmol/L |
| IGlar | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Overall | 0.71 mmol/L |
| IGlar | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Metformin Monotherapy | 0.67 mmol/L |
| IGlar | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Metformin+2nd OAD other than TZD | 0.71 mmol/L |
| IGlar | Within-subject Variation of Self Measured Plasma Glucose (SMPG) Before Breakfast | Metformin+TZD | 0.84 mmol/L |