Glipizide and Metformin Hydrochloride (Page 3 of 10)

Clinical Studies

Patients with Inadequate Glycemic Control on Diet and Exercise Alone

In a 24 week, double-blind, active-controlled, multicenter international clinical trial, patients with type 2 diabetes, whose hyperglycemia was not adequately controlled with diet and exercise alone (hemoglobin A1c [HbA1c ] > 7.5% and ≤ 12%, and fasting plasma glucose [FPG] < 300 mg/dL) were randomized to receive initial therapy with glipizide 5 mg, metformin 500 mg, glipizide and metformin hydrochloride tablets, 2.5 mg/250 mg, or glipizide and metformin hydrochloride tablets, 2.5 mg/500 mg. After 2 weeks, the dose was progressively increased (up to the 12 week visit) to a maximum of 4 tablets daily in divided doses as needed to reach a target mean daily glucose (MDG) of ≤ 130 mg/dL. Trial data at 24 weeks are summarized in Table 2.

Table 2: Active-Controlled Trial of Glipizide and Metformin Hydrochloride Tablets in Patients With Inadequate Glycemic Control on Diet and Exercise Alone: Summary of Trial Data at 24 Weeks
*
p < 0.001

Glipizide

5 mg Tablets

Metformin

500 mg Tablets

Glipizide and Metformin Hydrochloride Tablets, 2.5 mg/250 mg

Glipizide and Metformin Hydrochloride Tablets, 2.5 mg/500 mg

Mean Final Dose

16.7 mg

1749 mg

7.9 mg/791 mg

7.4 mg/1477 mg

Hemoglobin A 1c (%)

N = 168

N = 171

N = 166

N = 163

Baseline Mean

9.17

9.15

9.06

9.10

Final Mean

7.36

7.67

6.93

6.95

Adjusted Mean Change from Baseline

-1.77

-1.46

-2.15

-2.14

Difference from Glipizide

-0.38*

-0.37*

Difference from Metformin

-0.70*

-0.69*

% Patients with Final HbA1c < 7%

43.5%

35.1%

59.6%

57.1%

Fasting Plasma Glucose (mg/dL)

N = 169

N = 176

N = 170

N = 169

Baseline Mean

210.7

207.4

206.8

203.1

Final Mean

162.1

163.8

152.1

148.7

Adjusted Mean Change from Baseline

-46.2

-42.9

-54.2

-56.5

Difference from Glipizide

-8.0

-10.4

Difference from Metformin

-11.3

-13.6

After 24 weeks, treatment with glipizide and metformin hydrochloride tablets, 2.5 mg/250 mg and 2.5 mg/500 mg resulted in significantly greater reduction in HbA1c compared to glipizide and metformin therapy. Also, glipizide and metformin hydrochloride tablet, 2.5 mg/250 mg therapy resulted in significant reductions in FPG versus metformin therapy.

Increases above fasting glucose and insulin levels were determined at baseline and final study visits by measurement of plasma glucose and insulin for 3 hours following a standard mixed liquid meal. Treatment with glipizide and metformin hydrochloride tablets lowered the 3 hour postprandial glucose AUC, compared to baseline, to a significantly greater extent than did the glipizide and the metformin therapies. Compared to baseline, glipizide and metformin hydrochloride tablets enhanced the postprandial insulin response, but did not significantly affect fasting insulin levels.

There were no clinically meaningful differences in changes from baseline for all lipid parameters between glipizide and metformin hydrochloride tablet therapy and either metformin therapy or glipizide therapy. The adjusted mean changes from baseline in body weight were: glipizide and metformin hydrochloride tablets, 2.5 mg/250 mg, -0.4 kg; glipizide and metformin hydrochloride tablets, 2.5 mg/500 mg, -0.5 kg; glipizide, -0.2 kg; and metformin, -1.9 kg. Weight loss was greater with metformin than with glipizide and metformin hydrochloride tablets.

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