Composition for the oral administration of magnesium, in association with a composition for treating type 2 diabetes or the complications thereof

1. A method for delaying the onset or progression of long term type 2 diabetes complications selected from diabetic nephropathy, diabetic retinopathy, or diabetic cardiovascular disease comprising orally administering a magnesium matrix composition to a patient in need thereof thereby increasing intestinal and renal tolerance of long-term magnesium intake, wherein said magnesium matrix composition is a tablet consisting of the following components:

a)

MgCl 2 •n(H 2 O)

725.0 mg;

HPMC

183.0 mg;

mono-diglyceride behenate

 20.0 mg;

anhydrous lactose

 11.0 mg;

anhydrous colloidal silica

 11.0 mg;

and

a protective coating which slows down the dissolution of the magnesium at the gastric level, where n is a whole or fractional real number greater than 0 and less than or equal to 6;

b)

MgCl 2 •9/2H 2 O

725.0 mg;

HPMC

185.2 mg;

mono-diglyceride behenate

 19.8 mg;

anhydrous lactose

 11.0 mg;

anhydrous colloidal silica

 11.0 mg;

and

a protective coating which slows down the dissolution of the magnesium at the gastric level;

c)

MgCl 2 •9/2H 2 O

725.0 mg;

HPMC

185.0 mg;

mono-diglyceride behenate

 20.0 mg;

anhydrous lactose

 11.0 mg;

anhydrous colloidal silica

 11.0 mg;

and

a protective coating which slows down the dissolution of the magnesium at the gastric level;

d)

MgCl 2 •9/2H 2 O

725.0 mg;

HPMC

183.0 mg;

mono-diglyceride behenate

 20.0 mg;

anhydrous lactose

 11.0 mg;

anhydrous colloidal silica

 11.0 mg;

and

a protective coating which slows down the dissolution of the magnesium at the gastric level; or

e)

MgCl 2 •9/2H 2 O

725.0 mg;

HPMC

190.0 mg;

mono-diglyceride behenate

 21.5 mg;

anhydrous lactose

 10.0 mg;

anhydrous colloidal silica

 10.0 mg;

pyridoxine hydrochloride

 6.0 mg;

and

a protective coating which slows down the dissolution of the magnesium at the gastric level.

2. The method of claim 1 , wherein the protective coating is a film-coating with one or more layers.

3. The method of claim 1 , wherein said protective coating is a film-coating with one or more layers and represents 1.3% to 7.5% by weight relative to the weight of the matrix composition.

4. The method of claim 1 , wherein said protective coating is:

(a) a monolayer film-coating of shellac, or

(b) a two-layer film-coating, each layer comprising a substance chosen from shellac, cellulose ethers, and mixtures thereof.

5. The method of claim 1 , wherein said tablet is:

(I) a tablet with a homogeneous structure containing the magnesium chloride hydrate, or

(II) a tablet with a composite structure comprising:

(a) a core structure which is gastroresistant, or housed in a gastroresistant shell, said core structure containing 80% to 40% of the magnesium chloride hydrate, and

(b) an external layer that is hydrophilic, which dissolves in the stomach and contains 20% to 60% of the magnesium chloride hydrate.

6. The method of claim 1 , wherein n is between 2 and 6.

7. The method of claim 1 , wherein the magnesium matrix composition is administered in combination with a composition comprising, in a pharmaceutically acceptable medium, at least one pharmaceutically active agent selected from the group consisting of agents which stimulate insulin secretion, insulin sensitizers, agents which decrease glucogenesis, dipeptidyl peptidase-4 inhibitors and alpha-glucosidase inhibitors.

8. The method of claim 7 , wherein the composition comprises at least two pharmaceutically active agents.

9. The method of claim 1 , said method delaying the onset or progression of diabetic nephropathy.

10. The method of claim 1 , said method delaying the onset or progression of diabetic retinopathy.

11. The method of claim 1 , said method delaying the onset or progression of diabetic cardiovascular disease.

12. The method of claim 1 , wherein n is between 3 and 11/2.

13. The method of claim 1 , wherein n is 6/2, 7/2, 8/2, 9/2 or 10/2.

14. The method of claim 1 , wherein n is 9/2.

15. The method of claim 7 , wherein said magnesium matrix composition and said composition are administered simultaneously, separately or in a manner spread out over time.