Trial · NCT00081328

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

NCT00081328, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2014-12-16

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ConductScience Library. Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY). Trials, record NCT00081328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00081328

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY)
NCT number: NCT00081328
Status: Completed
Phases: Phase 3
Enrollment: 699 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Diabetes Mellitus, Type II
Interventions: Metformin, Rosiglitazone, Lifestyle Program
First posted: 2004-04-12
Last updated: 2021-07-30
Results first posted: 2014-12-16

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Failure (Loss of Glycemic Control)	Study duration - 2 years to 6.5 years of follow up from randomization	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)
Secondary	Insulin Sensitivity	24 months	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.
Secondary	Number of Serious Adverse Events	Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.	Number of serious adverse events reported during the trial. Participant could have multiple episodes reported.
Secondary	Insulin Secretion	24 months	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.
Secondary	Body Composition -- BMI	24 months	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.
Secondary	Body Composition -- Waist Circumference	24 months	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.
Secondary	Body Composition -- Bone Density	24 months	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.
Secondary	Body Composition -- Fat Mass	24 months	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.
Secondary	Comorbidity -- Hypertension	Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.	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.
Secondary	Comorbidity -- LDL Dyslipidemia	Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.	A diagnosis was made from out-of-range value \>= 130 mg/dL sustained over 6 months or put on lipid lowering medication.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Failure (Loss of Glycemic Control)	Study duration - 2 years to 6.5 years of follow up from randomization	The entire cohort of 699 participants was included in the analysis.	participants	NUMBER
SECONDARY	Insulin Sensitivity	24 months	Participants who were measured at 24 months and had not experienced treatment failure.	mL/uU	MEDIAN
SECONDARY	Number of Serious Adverse Events	Reported as occurred during study follow-up - 2 years to 6.5 years from randomization.	Entire cohort.	episodes of serious adverse event	NUMBER
SECONDARY	Insulin Secretion	24 months	Participants who were measured at 24 months and had not experience treatment failure.	uU/mL divided by mg/dL	MEDIAN
SECONDARY	Body Composition -- BMI	24 months	Cohort measured at 24 months and had not experienced treatment failure.	kg per meters squared	MEAN
SECONDARY	Body Composition -- Waist Circumference	24 months	Members of cohort measured at 24 months who had not experience treatment failure.	cm	MEAN
SECONDARY	Body Composition -- Bone Density	24 months	Members of the cohort measured at 24 months who did not experience treatment failure.	g/cm squared	MEAN
SECONDARY	Body Composition -- Fat Mass	24 months	Members of the cohort measured at 24 months who did not experience treatment failure.	kg	MEAN
SECONDARY	Comorbidity -- Hypertension	Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.	Entire cohort.	participants	NUMBER
SECONDARY	Comorbidity -- LDL Dyslipidemia	Data collected at baseline and during follow-up - 2 years to 6.5 years from randomization.	Entire cohort.	participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Treatment Failure (Loss of Glycemic Control)	1 Metformin Alone	Treatment failure	120		participants
Treatment Failure (Loss of Glycemic Control)	2 Metformin + Rosliglitazone	Treatment failure	90		participants
Treatment Failure (Loss of Glycemic Control)	3 Metformin + Lifestyle Program	Treatment failure	109		participants
Treatment Failure (Loss of Glycemic Control)	1 Metformin Alone	Did not fail treatment during trial	112		participants
Treatment Failure (Loss of Glycemic Control)	2 Metformin + Rosliglitazone	Did not fail treatment during trial	143		participants
Treatment Failure (Loss of Glycemic Control)	3 Metformin + Lifestyle Program	Did not fail treatment during trial	125		participants
Insulin Sensitivity	1 Metformin Alone		0.037	Inter-Quartile Range 0.023 to 0.061	mL/uU
Insulin Sensitivity	2 Metformin + Rosiglitazone		0.049	Inter-Quartile Range 0.031 to 0.068	mL/uU
Insulin Sensitivity	3 Metformin + Lifestyle Program		0.039	Inter-Quartile Range 0.027 to 0.064	mL/uU
Number of Serious Adverse Events	1 Metformin Alone		42		episodes of serious adverse event

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	1 Metformin Alone	232
Overall Study	STARTED	2 Metformin + Rosliglitazone	233
Overall Study	STARTED	3 Metformin + Lifestyle Program	234
Overall Study	COMPLETED	1 Metformin Alone	232
Overall Study	COMPLETED	2 Metformin + Rosliglitazone	233
Overall Study	COMPLETED	3 Metformin + Lifestyle Program	234
Overall Study	NOT COMPLETED	1 Metformin Alone	0
Overall Study	NOT COMPLETED	2 Metformin + Rosliglitazone	0
Overall Study	NOT COMPLETED	3 Metformin + Lifestyle Program	0

Source ClinicalTrials.gov

Adverse events39

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Skin rash on physical examination	Skin and subcutaneous tissue disorders	1 Metformin Alone	108	232	108
other	Skin rash on physical examination	Skin and subcutaneous tissue disorders	2 Metformin + Rosliglitazone	101	233	101
other	Skin rash on physical examination	Skin and subcutaneous tissue disorders	3 Metformin + Lifestyle Program	95	234	95
other	Gastrointestinal symptoms	Gastrointestinal disorders	1 Metformin Alone	129	232	129
other	Gastrointestinal symptoms	Gastrointestinal disorders	2 Metformin + Rosliglitazone	100	233	100
other	Gastrointestinal symptoms	Gastrointestinal disorders	3 Metformin + Lifestyle Program	136	234	136
other	Edema on physical examination	Skin and subcutaneous tissue disorders	1 Metformin Alone	17	232	17
other	Edema on physical examination	Skin and subcutaneous tissue disorders	2 Metformin + Rosliglitazone	17	233	17
other	Edema on physical examination	Skin and subcutaneous tissue disorders	3 Metformin + Lifestyle Program	17	234	17
other	Hyperglycemia symptoms	Endocrine disorders	1 Metformin Alone	115	232	115

1 to 10 of 39Source ClinicalTrials.gov

See all 39 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	1 Metformin Alone
Total, all-cause mortality	2 Metformin + Rosliglitazone
Total, all-cause mortality	3 Metformin + Lifestyle Program
Total, other adverse events	1 Metformin Alone	215	232
Total, other adverse events	2 Metformin + Rosliglitazone	196	233
Total, other adverse events	3 Metformin + Lifestyle Program	213	234
Total, serious adverse events	1 Metformin Alone	42	232
Total, serious adverse events	2 Metformin + Rosliglitazone	34	233
Total, serious adverse events	3 Metformin + Lifestyle Program	58	234

Source ClinicalTrials.gov

Papers78

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17448130	BACKGROUND	PubMed
19244566	BACKGROUND	PubMed
19774104	BACKGROUND	PubMed
19823189	BACKGROUND	PubMed
20519658	RESULT	PubMed
20962021	RESULT	PubMed
21357794	RESULT	PubMed
21836107	RESULT	PubMed
22332798	RESULT	PubMed
22369102	RESULT	PubMed

1 to 10 of 78

See all 78 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK061230	TODAY2 Phase 2 (T2P2): Long-Term Post-Intervention Follow-Up	BRAFFETT, BARBARA HALINA; ZEITLER, PHILIP S.	GEORGE WASHINGTON UNIVERSITY	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2001 to 2019

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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