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Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) (TODAY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00081328
Recruitment Status : Completed
First Posted : April 12, 2004
Results First Posted : December 16, 2014
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Kimberly, George Washington University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type II
Interventions Drug: Metformin
Drug: Rosiglitazone
Behavioral: Lifestyle Program
Enrollment 699
Recruitment Details Participants were recruited from July 2004 to February 2009. Participants were recruited from the patient populations of pediatric endocrine clinics at the participating study clinical centers, including satellite clinics. Posters announced the study. Study staff approached youth and their families during medical visits.
Pre-assignment Details Prior to randomization, eligible subjects entered a 2-6 month run-in period, with goals of weaning from non-study diabetes medications, tolerating metformin at 1000 mg bid but no less than 500 mg bid, attaining glycemic control on metformin alone, mastering standard diabetes education, and adhering to study medication and visit attendance.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description

Metformin alone

Metformin: capsule, 1000 mg bid, provided encapsulated in weekly packets

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid, provided encapsulated in weekly packets

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid, encapsulated, provided in weekly packets

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Period Title: Overall Study
Started 232 233 234
Completed 232 233 234
Not Completed 0 0 0
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosiglitazone 3 Metformin + Lifestyle Program Total
Hide Arm/Group Description

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Total of all reporting groups
Overall Number of Baseline Participants 232 233 234 699
Hide Baseline Analysis Population Description
Age 10–17 years with T2D according to American Diabetes Association criteria for less than 2 years, body mass index (BMI) >=85th percentile, negative diabetes autoantibodies, fasting c-peptide >0.6 ng/mL, and an adult caregiver willing to actively support study participation.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 232 participants 233 participants 234 participants 699 participants
14.1  (1.9) 14.1  (2.1) 13.8  (2.0) 14.0  (2.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 232 participants 233 participants 234 participants 699 participants
Female
146
  62.9%
152
  65.2%
154
  65.8%
452
  64.7%
Male
86
  37.1%
81
  34.8%
80
  34.2%
247
  35.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants 233 participants 234 participants 699 participants
American Indian 12 16 13 41
Black Non-Hispanic 77 64 86 227
Hispanic 91 101 86 278
White Non-Hispanic 49 47 46 142
Asian Non-Hispanic 3 5 3 11
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 232 participants 233 participants 234 participants 699 participants
232 233 234 699
Body mass index z-score  
Mean (Standard Deviation)
Unit of measure:  Z-score
Number Analyzed 232 participants 233 participants 234 participants 699 participants
2.27  (0.45) 2.22  (0.49) 2.18  (0.46) 2.23  (0.47)
Percent overweight  
Mean (Standard Deviation)
Unit of measure:  100% X (BMI-50th %ile)/50th %ile
Number Analyzed 232 participants 233 participants 234 participants 699 participants
82.1  (38.3) 79.1  (38.1) 75.6  (35.3) 78.9  (37.3)
Duration of diabetes  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 232 participants 233 participants 234 participants 699 participants
7.8  (6.0) 8.0  (5.7) 7.6  (5.8) 7.8  (5.8)
Total annual household income  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants 233 participants 234 participants 699 participants
< $25,000 81 86 92 259
$25,000-49,999 83 61 66 210
>=$50,000 44 58 53 155
unknown 24 28 23 75
Highest household education level  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants 233 participants 234 participants 699 participants
Less than high school 60 60 62 182
High school, GED, business or technical 57 49 66 172
College no degree 77 78 63 218
Graduate degree 35 41 38 114
Unknown 3 5 5 13
Tanner stage by physical examination   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants 233 participants 234 participants 699 participants
4 or 5 209 207 204 620
1, 2, or 3 23 26 30 79
[1]
Measure Description: Tanner stage is a standard 5-point scale of pubertal maturity from 1 (pre-pubertal) to 5 (post-pubertal).
Nuclear family history of diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants 233 participants 234 participants 699 participants
No 97 93 86 276
Yes 131 133 143 407
Unknown 4 7 5 16
Nuclear family + grandparents history of diabetes  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 232 participants 233 participants 234 participants 699 participants
No 17 26 29 72
Yes 211 200 200 611
Unknown 4 7 5 16
Insulin sensitivity (inverse of fasting insulin from OGTT)  
Median (Inter-Quartile Range)
Unit of measure:  mL/uU
Number Analyzed 232 participants 233 participants 234 participants 699 participants
.036
(.025 to .050)
.040
(.028 to .064)
.040
(.027 to .067)
.039
(.027 to .060)
Insulinogenic index from OGTT  
Median (Inter-Quartile Range)
Unit of measure:  uU/mL divided by mg/dL
Number Analyzed 232 participants 233 participants 234 participants 699 participants
1.02
(.47 to 1.98)
.92
(.47 to 1.58)
.87
(.47 to 1.89)
.93
(.47 to 1.85)
Body mass index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg per m squared
Number Analyzed 232 participants 233 participants 234 participants 699 participants
35.8  (8.1) 35.0  (7.7) 34.1  (7.1) 34.9  (7.6)
Waist circumference  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 232 participants 233 participants 234 participants 699 participants
110.4  (16.6) 109.0  (17.0) 106.6  (16.2) 108.6  (16.7)
Fat mass from DXA  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 232 participants 233 participants 234 participants 699 participants
33.7  (9.9) 33.5  (10.2) 32.6  (9.8) 33.3  (10.0)
Bone density from DXA  
Mean (Standard Deviation)
Unit of measure:  G per cm squared
Number Analyzed 232 participants 233 participants 234 participants 699 participants
1.09  (.12) 1.10  (.13) 1.08  (.12) 1.09  (.13)
1.Primary Outcome
Title Treatment Failure (Loss of Glycemic Control)
Hide Description Defined as A1c persistently >=8% over a 6-month period or persistent metabolic decompensation (inability to wean insulin within 3 months of initiation or the occurrence of a second episode within three months of discontinuing insulin)
Time Frame Study duration - 2 years to 6.5 years of follow up from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
The entire cohort of 699 participants was included in the analysis.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 232 233 234
Measure Type: Number
Unit of Measure: participants
Treatment failure 120 90 109
Did not fail treatment during trial 112 143 125
2.Secondary Outcome
Title Insulin Sensitivity
Hide Description All participants were followed to 24 months. Insulin sensitivity is measured from OGTT as inverse of fasting insulin (mL/uU). The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were measured at 24 months and had not experienced treatment failure.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosiglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 167 157 167
Median (Inter-Quartile Range)
Unit of Measure: mL/uU
0.037
(0.023 to 0.061)
0.049
(0.031 to 0.068)
0.039
(0.027 to 0.064)
3.Secondary Outcome
Title Safety
Hide Description Number of serious adverse events reported during the trial. Participant could have multiple episodes reported.
Time Frame Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
Entire cohort.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosiglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 232 233 234
Measure Type: Number
Unit of Measure: episodes of serious adverse event
42 34 58
4.Secondary Outcome
Title Insulin Secretion
Hide Description Insulinogenic index determined from OGTT as difference in insulin at 30 minutes minus 0 minutes divided by difference in glucose at 30 minutes minus 0 minutes. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were measured at 24 months and had not experience treatment failure.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 150 147 155
Median (Inter-Quartile Range)
Unit of Measure: uU/mL divided by mg/dL
.75
(.33 to 1.39)
.83
(.28 to 1.38)
.71
(.26 to 1.69)
5.Secondary Outcome
Title Body Composition -- BMI
Hide Description Body mass index (BMI) measured in kg per meters squared. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Cohort measured at 24 months and had not experienced treatment failure.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 132 138 134
Mean (Standard Deviation)
Unit of Measure: kg per meters squared
36.7  (9.1) 38.2  (8.1) 35.3  (8.4)
6.Secondary Outcome
Title Body Composition -- Waist Circumference
Hide Description Waist circumference (cm) measured at the iliac crest at its outermost point with the measuring tape placed around the participant in a horizontal plane parallel to the floor at the mark and the measurement teken at the end of normal expiration without the tape compressing the skin. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Members of cohort measured at 24 months who had not experience treatment failure.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 132 138 134
Mean (Standard Deviation)
Unit of Measure: cm
110.8  (17.5) 114.0  (16.3) 108.6  (16.7)
7.Secondary Outcome
Title Body Composition -- Bone Density
Hide Description Measured by DXA, both whole body scan and AP-spine scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Members of the cohort measured at 24 months who did not experience treatment failure.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 132 138 134
Mean (Standard Deviation)
Unit of Measure: g/cm squared
1.15  (.10) 1.15  (.11) 1.15  (.12)
8.Secondary Outcome
Title Body Composition -- Fat Mass
Hide Description Determined by DXA whole body scan. The analysis sample includes only participants with 24 month data who had not experienced the primary outcome by that time. In addition, in about 1/3 of participants DXA scans could not be obtained on participants weighing more than 300 pounds (136 kg), the upper limit in size set by the machine manufacturers. Scans were considered invalid if a body part (e.g., arm, leg) was completely off or partially off the scanner, there was hand-hip overlap, or there was motion or movement during the scan.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
Members of the cohort measured at 24 months who did not experience treatment failure.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 132 138 134
Mean (Standard Deviation)
Unit of Measure: kg
36.1  (12.0) 39.7  (10.5) 32.2  (9.4)
9.Secondary Outcome
Title Comorbidity -- Hypertension
Hide Description A diagnosis was made by an out-of-range value >=95th percentile or systolic >=130 or diastolic >=80 sustained over 6 months or on an anti-hypertensive medication.
Time Frame Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
Entire cohort.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 232 233 234
Measure Type: Number
Unit of Measure: participants
57 53 45
10.Secondary Outcome
Title Comorbidity -- LDL Dyslipidemia
Hide Description A diagnosis was made from out-of-range value >= 130 mg/dL sustained over 6 months or put on lipid lowering medication.
Time Frame Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
Entire cohort.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 232 233 234
Measure Type: Number
Unit of Measure: participants
18 16 15
11.Secondary Outcome
Title Comorbidity -- Triglycerides Dyslipidemia
Hide Description A diagnosis was made by an out-of-range value >=150 mg/dL sustained over 6 months or on appropriate lipid lowering medication.
Time Frame Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
Entire cohort.
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description:

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

Overall Number of Participants Analyzed 232 233 234
Measure Type: Number
Unit of Measure: participants
20 28 22
Time Frame During the 2-6 month pre-randomization run-in period and during follow-up from 2-6.5 years.
Adverse Event Reporting Description Terminology and criteria standard for clinical trials conducted by NIH were used.
 
Arm/Group Title 1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Hide Arm/Group Description

Metformin alone

Metformin: capsule, 1000 mg bid

Metformin + Rosiglitazone

Metformin: capsule, 1000 mg bid

Rosiglitazone: capsule, 4 mg bid

Metformin + Lifestyle Program

Metformin: capsule, 1000 mg bid

Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study

All-Cause Mortality
1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/232 (18.10%)      34/233 (14.59%)      58/234 (24.79%)    
Endocrine disorders       
Diabetic ketoacidosis *  5/232 (2.16%)  5 3/233 (1.29%)  3 3/234 (1.28%)  3
Hyperglycemia *  3/232 (1.29%)  3 5/233 (2.15%)  5 2/234 (0.85%)  2
Hypoglycemia *  1/232 (0.43%)  1 1/233 (0.43%)  1 2/234 (0.85%)  2
Lactic acidosis *  1/232 (0.43%)  1 0/233 (0.00%)  0 0/234 (0.00%)  0
General disorders       
all other *  32/232 (13.79%)  32 25/233 (10.73%)  25 51/234 (21.79%)  51
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
1 Metformin Alone 2 Metformin + Rosliglitazone 3 Metformin + Lifestyle Program
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   215/232 (92.67%)      196/233 (84.12%)      213/234 (91.03%)    
Endocrine disorders       
Hyperglycemia symptoms * [1]  115/232 (49.57%)  115 98/233 (42.06%)  98 103/234 (44.02%)  103
Mild hypoglycemia *  10/232 (4.31%)  10 19/233 (8.15%)  19 8/234 (3.42%)  8
Gastrointestinal disorders       
Gastrointestinal symptoms * [2]  129/232 (55.60%)  129 100/233 (42.92%)  100 136/234 (58.12%)  136
Infections and infestations       
Infection requiring medical attention *  149/232 (64.22%)  149 120/233 (51.50%)  120 151/234 (64.53%)  151
Musculoskeletal and connective tissue disorders       
Sprain or fracture requiring medical attention *  66/232 (28.45%)  66 53/233 (22.75%)  53 64/234 (27.35%)  64
Muscle ache or pain *  68/232 (29.31%)  68 53/233 (22.75%)  53 77/234 (32.91%)  77
Skin and subcutaneous tissue disorders       
Skin rash on physical examination *  108/232 (46.55%)  108 101/233 (43.35%)  101 95/234 (40.60%)  95
Edema on physical examination *  17/232 (7.33%)  17 17/233 (7.30%)  17 17/234 (7.26%)  17
*
Indicates events were collected by non-systematic assessment
[1]
Symptoms of diabetes out of control included nocturia more than once a night on a regular basis, enuresis, increased thirst, urinating more often than usual.
[2]
Frequent stomach pains, bloating, nausea, diarrhea, or loss of appetite.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
This work was conducted by a collaborative group. All investigators in the study group adhere to the Publications & Presentations Policy. The policy spells out procedures for proposing, developing, and submitting publications and presentations using study data. Once results have been published or presented, all members of the study group are free to discuss them.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Kathryn Hirst, Coordinating Center PI
Organization: TODAY Coordinating Center at George Washington University Biostatistics Center
Phone: 301-881-9260 ext 8025
EMail: khirst@bsc.gwu.edu
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Kimberly, George Washington University
ClinicalTrials.gov Identifier: NCT00081328     History of Changes
Other Study ID Numbers: IND - DK61230-TODAY
First Submitted: April 8, 2004
First Posted: April 12, 2004
Results First Submitted: September 26, 2014
Results First Posted: December 16, 2014
Last Update Posted: July 30, 2019