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Methods for administering long-lasting hypoglycemic agents

A technology of incretin and plasma, which is applied in the field of administering long-acting hypoglycemic drugs, and can solve the problem that therapeutic treatment of diabetes is not feasible

Inactive Publication Date: 2009-08-26
SMITHKLINE BECKMAN CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, exogenous administration of native GLP-1 as a therapeutic treatment of diabetes is currently not feasible

Method used

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  • Methods for administering long-lasting hypoglycemic agents
  • Methods for administering long-lasting hypoglycemic agents
  • Methods for administering long-lasting hypoglycemic agents

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0095]This was a single-blind, placebo-controlled dose escalation study in which a pharmaceutical composition comprising SEQ ID NO: 1 (0.25 mg-104 mg) was administered subcutaneously to the abdomen of healthy subjects.

[0096] Thirty-nine healthy male and female subjects participated in the study. Five groups of healthy subjects received the following two doses of the pharmaceutical composition comprising SEQ ID NO: 1 once a week by intraperitoneal subcutaneous injection: Group 1 (0.25 mg+1 mg); Group 2 (3 mg+6 mg ); Group 3 (16mg+24mg); Group 4 (48mg+60mg); and Group 5 (80mg+104mg). In Groups 1-4, 6 subjects were randomized to receive active compound and 2 subjects were randomized to receive placebo. In Group 5, 5 subjects were randomized to receive active compound and 2 subjects were randomized to receive placebo. Thus, 29 subjects received active treatment and 10 subjects received placebo. Exposure to the pharmaceutical composition comprising SEQ ID NO: 1 increased in a...

Embodiment 2

[0100] This was a single-blind, placebo-controlled, multiple-dose study in subjects with T2DM. Fifty-four male and female subjects participated in the study. Participants were either on a diet or taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea. Subjects taking metformin and / or sulfonylureas prior to the start of the study were excluded from these treatments 2 weeks prior to the first dose. Subjects were randomized to receive placebo or a pharmaceutical composition comprising SEQ ID NO: 1 by intraperitoneal subcutaneous injection once a week for two weeks as follows: Group 1 (9 mg+9 mg; 4 placebo, 14 active) ; Group 2 (16mg+16mg; 5 placebo, 12 active); Group 3 (32mg+32mg; 5 placebo, 14 active). Forty subjects were randomized to active treatment and 14 subjects were randomized to placebo.

[0101] Fifty-three subjects completed the study. One subject in Cohort 2 who was randomized to receive active treatment withdrew from the study before t...

Embodiment 3

[0105] The pharmacodynamic profiles of the subjects described in Example 2 are provided in this Example. The subjects received subcutaneous injections of placebo or a pharmaceutical composition comprising SEQ ID NO: 1 once a week for two weeks as follows: Group 1 (9 mg+9 mg; 4 placebos, 14 actives); Group 2 (16mg+16mg; 5 placebo, 12 active); Group 3 (32mg+32mg; 5 placebo, 14 active). Subjects were dosed on Days 1 and 8. The effect of SEQ ID NO: 1 on glucose and fructosamine in T2DM subjects was evaluated. Subjects with T2DM were either on a controlled diet or taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea, and had given up these treatments from 2 weeks before the first dose. Fasting and 24-hour glucose profiles were assessed at baseline and 24 hours after the first and second doses. Fructosamine was assessed at baseline and at follow-up visits (day 56 or 63) after day 3, day 21 and the last dose.

[0106] All subjects who received a prop...

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Abstract

The present invention relates to methods and pharmaceutical compositions relating to administering hypoglycemic agents and / or GLP-1 agonists wherein the mean maximum plasma concentration (Cmax) and / or Area Under the Curve (AUC) values of the hypoglycemic agent are increased and / or sustained.

Description

field of invention [0001] The present invention relates to methods and pharmaceutical compositions for administering long-acting hypoglycemic agents, and treatment regimens using compounds having GLP-1 activity and / or GLP-1 agonists. Background of the invention [0002] Hypoglycemic drugs are used in the treatment of type 1 and type 2 diabetes to lower the concentration of glucose in the blood. Insulinotropic peptides have been suggested as potential therapeutic agents for treating diabetes. Insulinotropic peptides include, but are not limited to, incretin hormones, such as gastric inhibitory peptide (gastric inhibitory peptide, GIP) and glucagon-like peptide-1 (GLP-1), and fragments, variants, and / or conjugates. Insulinotropic peptides also include, for example, exendin 3 and exendin 4. GLP-1 is a 36 amino acid long incretin hormone secreted by L cells in the intestine in response to food intake. GLP-1 has been shown to stimulate insulin secretion, decrease glucagon sec...

Claims

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Application Information

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IPC IPC(8): A61K38/26A61K38/17C07K14/605
Inventor 马克·A·布什杰茜卡·E·马修斯苏珊·E·沃克
Owner SMITHKLINE BECKMAN CORP
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