TAK-329 Glucose Clamp Study
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|ClinicalTrials.gov Identifier: NCT01311076|
Recruitment Status : Completed
First Posted : March 9, 2011
Last Update Posted : February 13, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: TAK-329 Drug: Insulin Drug: Placebo||Phase 1|
Type 1 diabetes mellitus (T1DM), also known as insulin-dependent diabetes mellitus or juvenile-onset diabetes, occurs primarily due to β-cell destruction, usually leading to absolute insulin deficiency. The condition is immune-mediated and is usually idiopathic. Tight glycemic control using intensive insulin therapy was shown in the Diabetes Control and Complications Trial (DCCT) to reduce rates of microvascular complications in T1DM; however, achieving and maintaining such control in T1DM using standard insulin therapy requires a high level of support and is associated with increased potential for hypoglycemia, increased weight gain and, in some patients, aggravation of cardiovascular risk factors including dyslipidemia.
TAK-329 is being developed by Takeda Global Research & Development Center, Inc. (TGRD) as an adjunct treatment to improve glycemic control in patients with type 1 diabetes mellitus who use insulin therapy.
This study will take place at 1 site in the United States. A total of 36 male and female adult participants with T1DM will take part in the study.
The study will last about 77 days, including a 28 days screening period, 4 cross-over treatment periods and a follow up period. Participants will be confined to the study clinic for 2 days in each period. Participants will also be contacted by phone 30 days following the last dose of study drug.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1, Randomized, Placebo- and Active-Controlled, 4-Period Crossover, Proof of Concept Glucose Clamp Study to Compare the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of Single Doses of TAK-329 With a Single Dose of a Subcutaneously-Injected Rapid-Acting Insulin Analog in Subjects With Type 1 Diabetes Mellitus.|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||January 2012|
|Experimental: TAK-329 50 mg||
TAK-329 50 mg, tablets, orally, single dose, one day.
|Experimental: TAK-329 200 mg||
TAK-329 200 mg, tablets, orally, single dose, one day.
|Active Comparator: Insulin 0.2 U/kg||
Insulin 0.2 U/kg, subcutaneous injection, single dose, one day.
|Placebo Comparator: Placebo||
TAK-329 placebo-matching tablets, orally, single dose, one day.
- (AUCGIR 0-360): Area Under the Curve of the Glucose Infusion Rate From Time 0 to 360 minutes post dose Pharmacodynamic Parameter. [ Time Frame: On Day 1 in Four Treatment Periods. ](AUCGIR 0-360) is measure of area under the curve of the glucose infusion rate from time 0 to 360 minutes (6 hours) post dose, measured in minutes during the glucose clamp procedure.
- GIRmax: Maximum Observed Glucose Infusion Rate Pharmacodynamic Parameter. [ Time Frame: On Day 1 in Four Treatment Periods. ]Maximum observed glucose infusion rate (GIRmax) is the peak glucose infusion rate of a drug after administration, obtained directly from the glucose infusion-time curve, measured in minutes during the glucose clamp procedure.
- TGIRmax: Time to Reach the Maximum Glucose Infusion Rate (GIRmax) Pharmacodynamic Parameter. [ Time Frame: On Day 1 in Four Treatment Periods. ]TGIRmax: Time to reach the maximum Glucose Infusion Rate (GIRmax), equal to time (hours) to GIRmax, measured in minutes during the glucose clamp procedure.
- Maximum Observed Pharmacodynamic Response (Emax) of Cortisol During Hypoglycemic Clamp. [ Time Frame: On Day 1 in Four Treatment Periods. ]The maximum observed increase or decrease (peak) effect for cortisol, based off sample collected at the start of the clamp procedure, 0 hours predose, and 0. 5, 1.0, 2, 3, 4 and 6 hours postdose. Hypoglycemic clamp procedure is a method for quantifying insulin secretion and resistance, used to measure glucose metabolism and insulin sensitivity.
- Area under the effect versus time curves (AUEC) of Cortisol During Hypoglycemic Clamp. [ Time Frame: On Day 1 in Four Treatment Periods. ]Area under the effect-time curve calculated using the linear trapezoidal rule for cortisol, based off sample collected at the start of the clamp procedure, 0 hours predose, and 0. 5, 1.0, 2, 3, 4 and 6 hours postdose. Hypoglycemic clamp procedure is a method for quantifying insulin secretion and resistance, used to measure glucose metabolism and insulin sensitivity.
- Incidence of Treatment-Emergent Adverse Events. [ Time Frame: After receiving first dose of study drug and within 30 days after receiving the last dose of study drug. ]Incidence of treatment-emergent adverse events (TEAE) are adverse events with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing.
- Incidence of Hypoglycemia. [ Time Frame: After receiving first dose of study drug and Day 7 +/-2 after receiving the last dose of study drug. ]Incidence of hypoglycemia (abnormal low blood sugar) classified into 4 categories: Severe Hypoglycemia (participant experiences confusion or disorientation requiring resuscitative action); Symptomatic Hypoglycemia (blood glucose of <55 mg/dL accompanied by clinically significant signs and symptoms of hypoglycemia); Biochemical Hypoglycemia (blood glucose <50 mg/dL preferably confirmed by second reading, regardless of accompanying symptoms or signs of hypoglycemia); and Other Hypoglycemia (any signs or symptoms considered by investigator indicative of hypoglycemia, regardless of glucose value).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01311076
|United States, California|
|Chula Vista, California, United States|
|Study Director:||Associate Medical Director, Clinical Science||Takeda|