PMID- 25531677
OWN - NLM
STAT- MEDLINE
DCOM- 20151110
LR  - 20221207
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Print)
IS  - 1520-9156 (Linking)
VI  - 17
IP  - 3
DP  - 2015 Mar
TI  - Evaluation of the long-term durability and glycemic control of fasting plasma 
      glucose and glycosylated hemoglobin for pioglitazone in Japanese patients with 
      type 2 diabetes.
PG  - 215-23
LID - 10.1089/dia.2014.0222 [doi]
AB  - BACKGROUND: This study applied a pharmacodynamic model-based approach to evaluate 
      the long-term durability and glycemic control of pioglitazone in comparison with 
      other oral glucose-lowering drugs in Japanese type 2 diabetes mellitus (T2DM) 
      patients. SUBJECTS AND METHODS: Japanese T2DM patients were enrolled in a 
      prospective, randomized, open-label, blinded-end point study and received 
      pioglitazone with or without other oral glucose-lowering drugs (excluding another 
      thiazolidinedione [TZD]) (n=293) or oral glucose-lowering drugs excluding TZD 
      (n=294). Treatment was adjusted to achieve glycosylated hemoglobin (HbA1c) <6.9%, 
      and samples for fasting plasma glucose (FPG) and HbA1c were collected over 2.5-4 
      years. A simultaneous cascading indirect response model structure was applied to 
      describe the time course of FPG and HbA1c. HbA1c levels were described using both 
      an FPG-dependent and an FPG-independent function. To account for titration, drug 
      effects for both treatment groups were implemented using a time-dependent Emax 
      model. RESULTS: Pioglitazone was superior in both time to maximum effect and the 
      magnitude of reduction achieved in FPG and HbA1c. A greater reduction in median 
      FPG (-21 mg/dL vs. -9 mg/dL) was observed with pioglitazone (P<0.05). Maximum 
      drug effect for FPG was predicted to occur earlier (11 months) for pioglitazone 
      than for the control group (14 months). The simulated additional reduction in FPG 
      and HbA1c achieved with pioglitazone was predicted to be maintained beyond the 
      currently observed study duration. CONCLUSIONS: Pioglitazone was found to result 
      in improved glycemic control and durability compared with control treatment. This 
      model-based approach enabled the quantification of differences in FPG and HbA1c 
      for both treatment groups and simulation to evaluate longer-term durability on 
      FPG and HbA1c.
FAU - Stringer, Frances
AU  - Stringer F
AD  - 1 Model Answers Pty Ltd. , Brisbane, Australia .
FAU - DeJongh, Joost
AU  - DeJongh J
FAU - Enya, Kazuaki
AU  - Enya K
FAU - Koumura, Emiko
AU  - Koumura E
FAU - Danhof, Meindert
AU  - Danhof M
FAU - Kaku, Kohei
AU  - Kaku K
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20141222
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Blood Glucose)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Thiazolidinediones)
RN  - 0 (hemoglobin A1c protein, human)
RN  - X4OV71U42S (Pioglitazone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Asian People
MH  - Blood Glucose/*drug effects
MH  - Diabetes Mellitus, Type 2/blood/*drug therapy
MH  - Drug Therapy, Combination/methods
MH  - Fasting/blood
MH  - Female
MH  - Glycated Hemoglobin/*drug effects
MH  - Humans
MH  - Hypoglycemic Agents/*therapeutic use
MH  - Japan
MH  - Male
MH  - Middle Aged
MH  - Pioglitazone
MH  - Prospective Studies
MH  - Thiazolidinediones/*therapeutic use
MH  - Time
MH  - Treatment Outcome
PMC - PMC4346657
EDAT- 2014/12/23 06:00
MHDA- 2015/11/11 06:00
PMCR- 2015/03/01
CRDT- 2014/12/23 06:00
PHST- 2014/12/23 06:00 [entrez]
PHST- 2014/12/23 06:00 [pubmed]
PHST- 2015/11/11 06:00 [medline]
PHST- 2015/03/01 00:00 [pmc-release]
AID - 10.1089/dia.2014.0222 [pii]
AID - 10.1089/dia.2014.0222 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2015 Mar;17(3):215-23. doi: 10.1089/dia.2014.0222. Epub 
      2014 Dec 22.