OTHER NON-INSULIN TYPE 2 DIABETES DRUGS
In addition to the above mentioned drug classes, there are 2 additional drugs on the market that have been approved for type 2 diabetes. These include bromocriptine, colesevelam and pramlintide.
Pramlintide is an synthetic analog of amylin which is co-secreted from the pancreas with insulin. Amylin acts to slow gastric emptying and decrease food intake thereby reducing insulin demand.
Colesevelam is a bile acid sequestrant which works by increasing bile acid removal from the body. It lowers blood cholesterol through the synthesis of new bile acids.
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BROMOCRIPTINE
Tradename (s) Cycloset™ Company(ies) VeroScience, LLC Available doses 0.8 mg tablet Dose per day 2 to 4 tablets once daily Side-effects nausea Elimination half-life 6 hours Metabolism extensively metabolized in the gastrointestinal tract and liver US patent status expired - generic US FDA status approved May 2009 for type 2 diabetes but previously approved in 1978 for other indications (see below) EMEA status approved for indications other than type 2 diabetes Indication Cycloset is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Comments Cycloset contains bromocriptine mesylate, an ergot derivative that is a dopamine receptor agonist. The mechanism by which Cycloset improves glycemic control is unknown.
Bromocriptine mesylate sold under the tradename Parlodel® by Novartis is indicated for the treatment of
- dysfunctions associated with hyperprolactinemia including amenorrhea with or without galactorrhea, infertility or hypogonadism,
- acromegaly
- the signs and symptoms of idiopathic or postencephalitic Parkinson’s disease
In 2008, the European Medicines Agency recommended updating the product information for ergot-derived dopamine agonists including bromocriptine with new warnings and contraindications in relation to the risk of fibrosis.
COLESEVELAM
Tradename (s) Welchol™ Company(ies) Daiichi Sankyo , Inc. Available doses 625 mg Dose per day 6 tablets once daily or 3 tablets twice daily Side-effects constipation Elimination half-life not applicable Metabolism not metabolized US patent status US FDA status approved January 2008 EMEA status not approved for type 2 diabetes
approved in March 2004 as cholesterol lowering drugIndication Colesevelam is indicated to improve glycemic control in adults with type 2 diabetes mellitus in combination with metformin, sulfonylureas, or insulin, either alone or in combination with other anti-diabetic agents. Comments Welchol was previously approved by the US-FDA in May 2000 as an adjunct to diet and exercise to reduce elevated low-density lipoprotein cholesterol (LDL-C) in patients with primary hyperlipidemia (Fredrickson Type IIa) as monotherapy or in combination with an hydroxymethyl-glutaryl-coenzym A (HMG CoA) reductase inhibitor.
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PRAMLINTIDE
Tradename(s) Symlin® Company(ies) Amylin Pharmaceuticals, Inc. Available doses 15 mcg, 30 mcg, 45 mcg, 60 mcg and 120 mcg as a 1000 mcg/ml, 1.5 ml pen-injector Dose per day prior to each meal Side-effects nausea Elimination half-life 1 hour Metabolism metabolized by the kidneys US patent status US FDA status approved March 2005 EMEA status not approved Indication Pramlintide is indicated for:
- Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin
- Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapyComments - Pramlintide is administered through subcutaneous injection.
- Pramlintide is a synthetic analog of human amylin.
