A Single-Dose Crossover Study of MK0893 in Patients With Type 2 Diabetes (0893-019 AM4)(COMPLETED)

Browse trials for

• Diabetes Mellitus 10,925
• Diabetes Mellitus, Type 2 9,359

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 22 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Study arms

• Experimental
  Propanolol + Placebo > Propanolol + MK0893

  Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893-matched placebo was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8).

  Drug: MK0893 · Drug: MK0893-matched Placebo · Drug: Propranolol Hydrochloride (HCL)

• Placebo comparator
  Propanolol + MK0893 > Propanolol + Placebo

  Participants received propanolol for 7 weeks. On Day -1 of Period 1 (Study Visit 6), single dose MK0893 was added and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8).

  Drug: MK0893 · Drug: MK0893-matched Placebo · Drug: Propranolol Hydrochloride (HCL)

Interventions

• DrugMK0893

  Single dose of MK0893 1000 mg (ten 100 mg tablets)

• DrugMK0893-matched Placebo

  Single dose of placebo to MK0893 (ten tablets)

• DrugPropranolol Hydrochloride (HCL)

  Propranolol tablets titrated up to 80 mg three times daily over a four week period. Total treatment was approximately 7 weeks.

Primary outcomes

1. Recovery Time (Rt[65] From Insulin-induced Hypoglycemia

   Rt(65) defined as the time to recover from hypoglycemia (blood glucose level of 50 mg/dL) to an arterialized venous blood glucose of 65 mg/dL. At t= -60 minutes on the morning of Day 1 (Visit 6) or Day 22 (Visit 8), a hypoglycemic clamp was used via an increased insulin infusion rate to achieve blood glucose concentrations of 50 mg/dL (2.8 mmol/L) within \~30-90 minutes. At the end of the 30-minute hypoglycemic clamp interval, insulin and glucose infusions were terminated, and the time to recover from hypoglycemia to 65 mg/dL Rt(65) was determined. Rt(65) was followed up to 270 minutes

   Time frame: From the time of hypoglycemic clamp (t=0 minutes) through 270 minutes

Secondary outcomes

1. Maximum Plasma Concentration (Cmax) and Concentration Average Over 8-12 Hours (C[Ave] 8-12 hr) Post Single Dose MK0893

   Cmax was the maximum or "peak" concentration of MK0893 observed after its administration. Approximate C(ave 8-12) was the MK0893 concentration average over 8-12 hours post-dose and was computed as the Area Under the Curve over 8-12 hours post-dose (AUC \[8-12\]) ÷ 4

   Time frame: From time of MK0893 administration through 24 hours post-dose

2. Plasma Concentration at 32 Hours (C[32hr]) Post Single Dose MK0893

   Plasma concentration of single dose MK0893 was measured from time of administration to 24 hours post-dose and extrapolated out to 32 hours post-dose using the plasma concentration vs. time curve

   Time frame: From time of MK0893 administration through estimated 32 hours post-dose

3. Number of Participants With An Adverse Event (AE)

   An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product.

   Time frame: From time of administration of study treatment through end of Post-Study (up to 21 days after administration of last dose of study treatment).

4. Number of Participants Who Discontinued Study Treatment Due To AEs

   An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the Sponsor's product, whether or not considered related to the use of the product. This also included any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the Sponsor's product.

   Time frame: From time of first administration of study treatment to time of last administration of study treatment (up to Day 21)

Baseline characteristics