Page last updated: 2024-11-05

2,4-thiazolidinedione and Fasting Hypoglycemia

2,4-thiazolidinedione has been researched along with Fasting Hypoglycemia in 9 studies

thiazolidine-2,4-dione: structure in first source
1,3-thiazolidine-2,4-dione : A thiazolidenedione carrying oxo substituents at positions 2 and 4.

Fasting Hypoglycemia: HYPOGLYCEMIA expressed in the postabsorptive state, after prolonged FASTING, or an overnight fast.

Research Excerpts

ExcerptRelevanceReference
"Patients with type 2 diabetes who added a sulphonylurea or a thiazolidinedione to ongoing metformin therapy on a date (index date) from January 2001 through January 2006 and who had at least one haemoglobin A1C (HbA1C) measurement in the 12-month period before the visit date were eligible."1.35Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study. ( Alvarez Guisasola, F; Krishnarajah, G; Lyu, R; Mavros, P; Tofé Povedano, S; Yin, D, 2008)

Research

Studies (9)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's5 (55.56)29.6817
2010's3 (33.33)24.3611
2020's1 (11.11)2.80

Authors

AuthorsStudies
Kodama, S1
Fujihara, K1
Ishiguro, H1
Matsubayashi, Y1
Kitazawa, M1
Iwanaga, M1
Yamada, T1
Kato, K1
Nakagawa, Y1
Tanaka, S1
Shimano, H1
Sone, H1
Umetsu, R1
Nishibata, Y1
Abe, J1
Suzuki, Y1
Hara, H1
Nagasawa, H1
Kinosada, Y1
Nakamura, M1
Araki, E1
Tanizawa, Y1
Tanaka, Y1
Taniguchi, A1
Koiwai, K1
Kim, G1
Salsali, A1
Woerle, HJ1
Broedl, UC1
Schernthaner, G1
Rosas-Guzmán, J1
Dotta, F1
Guerci, B1
Simó, R1
Festa, A1
Kiljański, J1
Zhou, M1
Gallwitz, B1
Jermendy, G1
Erdesz, D1
Nagy, L1
Yin, D2
Phatak, H1
Karve, S1
Engel, S1
Balkrishnan, R1
Mathieu, C1
Cuddihy, R1
Arakaki, RF1
Belin, RM1
Planquois, JM1
Lyons, JN1
Heilmann, CR1
Kawamori, R1
Kadowaki, T1
Ishida, H1
Zinman, B1
Hoogwerf, BJ1
Durán García, S1
Milton, DR1
Giaconia, JM1
Kim, DD1
Trautmann, ME1
Brodows, RG1
Alvarez Guisasola, F1
Tofé Povedano, S1
Krishnarajah, G1
Lyu, R1
Mavros, P1

Clinical Trials (3)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A 52-week, Randomised, Multi-centre, Parallel Group Study to Investigate the Safety and Efficacy of BI 10773 (10 mg or 25 mg Administered Orally Once Daily) as add-on Therapy to an Oral Antidiabetic Drug (Sulfonylurea, Biguanide, Thiazolidinedione, Alpha [NCT01368081]Phase 31,162 participants (Actual)Interventional2011-05-31Completed
Long Term Treatment With Exenatide Versus Glimepiride in Patients With Type 2 Diabetes Pretreated With Metformin (EUREXA: European Exenatide Study)[NCT00359762]Phase 31,029 participants (Actual)Interventional2006-09-30Completed
Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using Thiazolidinediones or Thiazolidinediones and Metformin[NCT00099320]Phase 3182 participants (Actual)Interventional2004-05-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Change From Baseline in HbA1c

Change from baseline in HbA1c after 52 weeks of treatment (NCT01368081)
Timeframe: Baseline and 52 weeks

Interventionpercentage of HbA1c (Least Squares Mean)
Sulfonylurea: Empa 10mg-0.93
Sulfonylurea: Empa 25mg-0.96
Sulfonylurea: Metformin-0.97
Biguanide: Empa 10mg-0.81
Biguanide: Empa 25mg-0.98
Thiazolidinedione: Empa 10mg-0.90
Thiazolidinedione: Empa 25mg-0.96
Alpha Glucosidase Inhibitor: Empa 10mg-0.87
Alpha Glucosidase Inhibitor: Empa 25mg-0.77
DPP-IV Inhibitor: Empa 10mg-1.00
DPP-IV Inhibitor: Empa 25mg-0.83
Glinide: Empa 10mg-0.98
Glinide: Empa 25mg-0.98

Confirmed Hypoglycaemic Adverse Events

Number of patients with confirmed hypoglycaemic adverse events (NCT01368081)
Timeframe: After the first drug intake until 7 days after the last treatment administration, up to 383 days

Interventionparticipants (Number)
Sulfonylurea: Empa 10mg6
Sulfonylurea: Empa 25mg9
Sulfonylurea: Metformin5
Biguanide: Empa 10mg0
Biguanide: Empa 25mg1
Thiazolidinedione: Empa 10mg2
Thiazolidinedione: Empa 25mg1
Alpha Glucosidase Inhibitor: Empa 10mg0
Alpha Glucosidase Inhibitor: Empa 25mg0
DPP-IV Inhibitor: Empa 10mg0
DPP-IV Inhibitor: Empa 25mg1
Glinide: Empa 10mg0
Glinide: Empa 25mg2

Number of Patients With Drug Related Adverse Events

Number of Patients With Drug Related Adverse Events after the first drug intake until 7 days after the last treatment administration, up to 383 days (NCT01368081)
Timeframe: After the first drug intake until 7 days after the last treatment administration, up to 383 days

Interventionparticipants (Number)
Sulfonylurea: Empa 10mg19
Sulfonylurea: Empa 25mg25
Sulfonylurea: Metformin13
Biguanide: Empa 10mg13
Biguanide: Empa 25mg9
Thiazolidinedione: Empa 10mg20
Thiazolidinedione: Empa 25mg19
Alpha Glucosidase Inhibitor: Empa 10mg7
Alpha Glucosidase Inhibitor: Empa 25mg5
DPP-IV Inhibitor: Empa 10mg9
DPP-IV Inhibitor: Empa 25mg18
Glinide: Empa 10mg9
Glinide: Empa 25mg9

Change in Body Weight From Baseline to Year 3

Change in Body weight from baseline to Year 3. (NCT00359762)
Timeframe: Baseline, Year 3 in Period II

Interventionkg (Least Squares Mean)
Exen + Met-3.92
Glim + Met1.47

Change in DI30/DG30 Ratio From Baseline to Endpoint

Change in DI30/DG30 ratio from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Interventionratio (Least Squares Mean)
Exen + Met12.10
Glim + Met0.91

Change in Disposition Index From Baseline to Endpoint

Change in disposition index from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Interventionratio (Least Squares Mean)
Exen + Met9.15
Glim + Met1.82

Change in Fasting Plasma Glucose From Baseline to Endpoint

Change in fasting plasma glucose from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Interventionmmol/L (Least Squares Mean)
Exen + Met-0.87
Glim + Met-0.41

Change in Fasting Proinsulin/Insulin Ratio From Baseline to Endpoint.

Change in fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Interventionratio (Least Squares Mean)
Exen + Met0.03
Glim + Met0.05

Change in HbA1c From Baseline to Endpoint

Change in HbA1c from baseline to endpoint. Endpoint for HbA1c was defined as the HbA1c measured at the treatment failure for patients reaching primary endpoint and was the last observation in study period II for other patients (either followed until the end of the study period II or discontinuing the study). (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Interventionpercentage of total hemoglobin (Least Squares Mean)
Exen + Met-0.36
Glim + Met-0.21

Change in HbA1c From Baseline to Year 2 for Patients Not Randomized at Entry in Period III

Change in HbA1c from baseline to Year 2. (NCT00359762)
Timeframe: Baseline in Period III, Year 2 in Period III

Interventionpercentage of total hemoglobin (Mean)
Glim + Met + Exen - Not Randomized-0.47

Change in HbA1c From Baseline to Year 2 for Patients Randomized at Entry in Period III

Change in HbA1c from baseline to Year 2. (NCT00359762)
Timeframe: Baseline in Period III, Year 2 in Period III

Interventionpercentage of total hemoglobin (Least Squares Mean)
Exen + Met + Glim - Randomized-0.19
Exen + Met + Pio or Rosi - Randomized-0.47

Change in HbA1c From Baseline to Year 3

Change in HbA1c from baseline to Year 3. (NCT00359762)
Timeframe: Baseline, Year 3 in Period II

Interventionpercentage of total hemoglobin (Least Squares Mean)
Exen + Met-0.30
Glim + Met-0.12

Change in HOMA-B From Baseline to Endpoint

Change in HOMA-B from baseline to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Interventionratio (Least Squares Mean)
Exen + Met5.56
Glim + Met19.92

Change in Postprandial (2 Hours) Plasma Glucose From Baseline to Endpoint

Change from baseline in postprandial (2 hours) plasma glucose to endpoint. (NCT00359762)
Timeframe: Baseline, end of Period II (up to 4.5 years)

Interventionmmol/L (Least Squares Mean)
Exen + Met-2.72
Glim + Met-0.53

Diastolic Blood Pressure at Year 3

Diastolic Blood pressure at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

InterventionmmHg (Least Squares Mean)
Exen + Met77.45
Glim + Met79.16

Disposition Index at Year 3

Disposition Index at Year 3. Disposition index was calculated as (DI30/DG30 ratio)/(HOMA index for insulin resistance (HOMA-IR)); where HOMA-IR=(fasting insulin (measured in pmol/L) x fasting glucose (measured in mmol/L))/(22.5 x 7.175). (NCT00359762)
Timeframe: Year 3 in Period II

Interventionratio (Least Squares Mean)
Exen + Met12.56
Glim + Met7.89

Fasting Plasma Glucose at Year 3

Fasting plasma glucose at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Interventionmmol/L (Least Squares Mean)
Exen + Met7.27
Glim + Met7.96

Fasting Proinsulin/Insulin Ratio at Year 3

Fasting proinsulin (measured in pmol/L)/insulin (measured in pmol/L) ratio at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Interventionratio (Least Squares Mean)
Exen + Met0.22
Glim + Met0.23

Heart Rate at Year 3

Heart rate at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Interventionbeats per minute (Least Squares Mean)
Exen + Met73.51
Glim + Met74.23

High-density Lipoprotein (HDL) Cholesterol at Year 3

HDL Cholesterol at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Interventionmmol/L (Least Squares Mean)
Exen + Met1.31
Glim + Met1.25

Homeostasis Model Assessment of Beta-cell Function (HOMA-B) at Year 3

HOMA-B at Year 3. HOMA-B is an index of beta-cell function and was calculated as: HOMA-B = (20 x fasting insulin (measured in pmol/L))/((fasting glucose (measured in mmol/L) - 3.5) x 7.175). (NCT00359762)
Timeframe: Year 3 in Period II

Interventionratio (Least Squares Mean)
Exen + Met66.86
Glim + Met68.52

Hypoglycemia Rate Per Year

All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)

Interventionevents per subject-year (Least Squares Mean)
Exen + Met1.52
Glim + Met5.32

Hypoglycemia Rate Per Year in Period III

All hypoglycemia episodes were taken into account. Severe hypoglycemia: event requiring assistance of another person to administer carbohydrate, glucagons, or other resuscitative actions; Documented symptomatic hypoglycemia: event with typical symptoms accompanied by a measured plasma glucose concentration <=70 mg/dL; Asymptomatic hypoglycemia: event not accompanied by typical symptoms but with a measured plasma glucose concentration <=70 mg/dL; Probable symptomatic hypoglycemia: event with symptoms not accompanied by a plasma glucose determination. (NCT00359762)
Timeframe: Start of Period III to end of study

Interventionevents per subject-year (Mean)
Exen + Metformin + Glim - Randomized2.78
Exen + Met + Pio or Rosi - Randomized0.60
Glim + Met + Exen - Not Randomized4.62

Postprandial (2 Hours) Plasma Glucose at Year 3

Postprandial (2 hours) plasma glucose at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Interventionmmol/L (Least Squares Mean)
Exen + Met12.65
Glim + Met15.45

Ratio of the 30 Minute Increment in Plasma Insulin Concentration and the 30 Minute Increment in Plasma Glucose During the Oral Glucose Tolerance Test (DI30/DG30 Ratio) at Year 3

DI30/DG30 at Year 3. DI30/DG30 ratio was calculated as (30 minute post prandial insulin - fasting insulin) (measured in pmol/L)/(30 minute post prandial glucose - fasting glucose) (measured in mmol/L). (NCT00359762)
Timeframe: Year 3 in Period II

Interventionratio (Least Squares Mean)
Exen + Met25.81
Glim + Met26.38

Systolic Blood Pressure at Year 3

Systolic Blood pressure at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

InterventionmmHg (Least Squares Mean)
Exen + Met130.58
Glim + Met135.78

Time to Treatment Failure

Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)

Interventionweek (Median)
Exen + Met180.0
Glim + Met142.1

Total Cholesterol at Year 3

Total Cholesterol at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Interventionmmol/L (Least Squares Mean)
Exen + Met4.77
Glim + Met4.75

Triglycerides at Year 3

Triglycerides at Year 3. (NCT00359762)
Timeframe: Year 3 in Period II

Interventionmmol/L (Least Squares Mean)
Exen + Met1.69
Glim + Met1.95

Number of Patients With Treatment Failure

Treatment failure is defined as one of the following:1. HbA1c exceeding 9% at any visit after the initial 3 months of treatment (i.e., earliest at Month 6), on the maximally tolerated dose of antidiabetic agents. 2. HbA1c exceeding 7% at 2 consecutive visits 3 months apart, after the initial 6 months of treatment (i.e., earliest at Month 9), on the maximally tolerated dose of antidiabetic agents. (NCT00359762)
Timeframe: Baseline to end of Period II (up to 4.5 years)

,
Interventionnumber of patients (Number)
Number of patients with treatment failureNumber of patients censored
Exen + Met203287
Glim + Met262225

Reviews

1 review available for 2,4-thiazolidinedione and Fasting Hypoglycemia

ArticleYear
Network meta-analysis of glucose-lowering drug treatment regimens with the potential risk of hypoglycemia in patients with type 2 diabetes mellitus in terms of glycemic control and severe hypoglycemia.
    Journal of investigative medicine : the official publication of the American Federation for Clinical Research, 2023, Volume: 71, Issue:4

    Topics: Blood Glucose; Diabetes Mellitus, Type 2; Glucose; Glycated Hemoglobin; Glycemic Control; Humans; Hy

2023

Trials

4 trials available for 2,4-thiazolidinedione and Fasting Hypoglycemia

ArticleYear
Long-term treatment with empagliflozin as add-on to oral antidiabetes therapy in Japanese patients with type 2 diabetes mellitus.
    Diabetes, obesity & metabolism, 2015, Volume: 17, Issue:7

    Topics: Adult; Aged; Benzhydryl Compounds; Biguanides; Blood Glucose; Diabetes Mellitus, Type 2; Dipeptidyl-

2015
Treatment escalation options for patients with type 2 diabetes after failure of exenatide twice daily or glimepiride added to metformin: results from the prospective European Exenatide (EUREXA) study.
    Diabetes, obesity & metabolism, 2015, Volume: 17, Issue:7

    Topics: Adult; Aged; Blood Glucose; Body Mass Index; Diabetes Mellitus, Type 2; Drug Administration Schedule

2015
A comparison between simplified and intensive dose-titration algorithms using AIR inhaled insulin for insulin-naive patients with type 2 diabetes in a randomized noninferiority trial.
    Diabetes technology & therapeutics, 2009, Volume: 11 Suppl 2

    Topics: Administration, Inhalation; Adult; Aged; Body Mass Index; Diabetes Mellitus, Type 2; Drug Therapy, C

2009
The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial.
    Annals of internal medicine, 2007, Apr-03, Volume: 146, Issue:7

    Topics: Adult; Aged; Blood Glucose; Blood Glucose Self-Monitoring; Diabetes Mellitus, Type 2; Double-Blind M

2007

Other Studies

4 other studies available for 2,4-thiazolidinedione and Fasting Hypoglycemia

ArticleYear
[Evaluation of the association between the use of oral anti-hyperglycemic agents and hypoglycemia in Japan by data mining of the Japanese Adverse Drug Event Report (JADER) database].
    Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan, 2014, Volume: 134, Issue:2

    Topics: Acarbose; Administration, Oral; Adverse Drug Reaction Reporting Systems; Benzamides; Biguanides; Dat

2014
Outcomes of adding second hypoglycemic drug after metformin monotherapy failure among type 2 diabetes in Hungary.
    Health and quality of life outcomes, 2008, Oct-31, Volume: 6

    Topics: Adult; Aged; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Female; Glycated Hemoglobin; Huma

2008
[Achieving better control of blood sugar--understanding of oral hypoglycemic agents according to their characteristics in pharmacological action mechanism (discussion)].
    Nihon rinsho. Japanese journal of clinical medicine, 2004, Volume: 62, Issue:4

    Topics: Administration, Oral; Cardiovascular Diseases; Cyclohexanes; Diabetes Complications; Diabetes Mellit

2004
Hypoglycaemic symptoms, treatment satisfaction, adherence and their associations with glycaemic goal in patients with type 2 diabetes mellitus: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) Study.
    Diabetes, obesity & metabolism, 2008, Volume: 10 Suppl 1

    Topics: Blood Glucose; Cross-Sectional Studies; Diabetes Mellitus, Type 2; Drug Therapy, Combination; Europe

2008